NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS

  • 모델명 / 제조번호(시리얼번호)
    103572, 60282369, 60292621, 60296125, 60296126, 60312269, 60331390, 60895117 and 61116574.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 제조사 모회사 (2017)
  • 제조사 의견
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    103048, 7878946, 60242394, 60263535, 60282365, 60292619, 60292624, 60296116, 60302284, 60312266, 60317606, 60328157, 60331375, 60492607, 60548462, 60558662, 60582735, 60612398, 60625481, 60631130, 60662632, 60686881, 60711155, 60756483, 60805428, 60823401, 60895104, 60896872, 60959680, 60994894, 61050231, 61133857, 61158294, 61198698, 61248778, 61350333 and 61410286.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    111131, 7881879, 60263536, 60282367, 60292618, 60292620, 60292623, 60296117, 60296118, 60296119, 60302285, 60312260, 60315642, 60317607, 60321945, 60328158, 60328161, 60331376, 60334521, 60362084, 60372785, 60372786, 60380755, 60457190, 60457195, 60460069, 60472448, 60476747, 60480951, 60492608, 60497690, 60502850, 60512205, 60518609, 60523102, 60538366, 60542934, 60554995, 60562933, 60566980, 60575470, 60578770, 60582736, 60593836, 60595803, 60608104, 60612399, 60616286, 60621119, 60625489, 60631132, 60634788, 60640822, 60649151, 60660341, 60667948, 60677455, 60682185, 60686882, 60692576, 60701924, 60711156, 60717978, 60732156, 60732158, 60748243, 60752980, 60760509, 60765124, 60775800, 60782863, 60785781, 60790429, 60801746, 60809057, 60816237, 60818763, 60823402, 60840790, 60847122, 60854122, 60867943, 60873473, 60881693, 60895096, 60895105, 60909839, 60917515, 60929865, 60929872, 60934274, 60942490, 60949438, 60949442, 60959681, 60967997, 60969509, 60979127, 60983699, 60987129, 60994895, 61006364, 61006366, 61022793, 61022794, 61029263, 61034993, 61045015, 61050232, 61057516, 61064204, 61090790, 61097029, 61100563, 61113637, 61116565, 61121501, 61128962, 61133865, 61138441, 61138448, 61149375, 61154238, 61158295, 61174187, 61181644, 61181648, 61193863, 61198699, 61211009, 61216067, 61225956, 61231012, 61245335, 61248779, 61253733, 61259044, 61259045, 61259059, 61262894, 61262895, 61262903, 61262904, 61262905, 61267824, 61267825, 61267843, 61272582, 61272598, 61277589, 61280559, 61280560, 61285875, 61285890, 61285892, 61289981, 61289994, 61295484, 61295485, 61298635, 61302107, 61302116, 61307076, 61307086, 61311098, 61315686, 61315687, 61319839, 61319850, 61324494, 61324506, 61324507, 61329234, 61334540, 61338267, 61338286, 61344102, 61344103, 61350284, 61350285, 61350286, 61355734, 61355735, 61355736, 61355743, 61355744, 61355745, 61360859, 61360860, 61365234, 61365248, 61370239, 61370249, 61370250, 61376578, 61376588, 61376589, 61380424, 61380425, 61380436, 61380437, 61380438, 61386637, 61386638, 61390830, 61390831, 61395038, 61395039, 61395040, 61399697, 61399698 and 61399699.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    102857, 103992, 112386, 113494, 7878228, 7879513, 7879571, 7880358, 7881615, 7881898, 7883401, 60218034, 60218040, 60242847, 60249205, 60251625, 60251626, 60256223, 60256224, 60258856, 60258857, 60260762, 60260768, 60260769, 60264875, 60264883, 60267795, 60267796, 60267797, 60269817, 60269818, 60273902, 60273903, 60273904, 60273905, 60299527, 60299528, 60299536, 60302286, 60302287, 60307218, 60307219, 60307228, 60312267, 60315643, 60317608, 60317609, 60321946, 60321947, 60326184, 60326185, 60326186, 60328162, 60328163, 60331377, 60331378, 60331393, 60334522, 60334523, 60334524, 60336051, 60336052, 60336053, 60339640, 60339641, 60350411, 60350412, 60352909, 60352914, 60355704, 60355705, 60358828, 60358829, 60362082, 60362085, 60362086, 60362087, 60365649, 60365650, 60369191, 60369192, 60369193, 60369198, 60372787, 60372788, 60374326, 60374327, 60374328, 60374337, 60374338, 60380756, 60384324, 60457196, 60460070, 60463940, 60472449, 60476748, 60476749, 60476750, 60480948, 60480949, 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  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    109168, 7878944, 7879126, 7879570, 7879652, 7879676, 7883382, 7883854, 60218033, 60232198, 60237941, 60242848, 60249206, 60251627, 60251629, 60256225, 60256226, 60258858, 60258859, 60258860, 60258865, 60260763, 60260764, 60260770, 60264876, 60264877, 60264884, 60264886, 60267798, 60267799, 60269819, 60269820, 60273906, 60273907, 60296120, 60296121, 60299529, 60299530, 60299531, 60302288, 60302289, 60307220, 60307221, 60307222, 60312261, 60312262, 60312268, 60315644, 60315645, 60317610, 60317616, 60321948, 60321949, 60321950, 60326187, 60326188, 60328164, 60331379, 60331380, 60331381, 60334525, 60334526, 60334527, 60334528, 60336054, 60336055, 60336056, 60339642, 60339643, 60350413, 60352910, 60352911, 60352915, 60355706, 60355707, 60355708, 60358830, 60358831, 60358832, 60362088, 60362089, 60362090, 60365651, 60365652, 60365653, 60369194, 60369195, 60369199, 60372789, 60372790, 60374324, 60374329, 60374330, 60374331, 60374339, 60374340, 60380757, 60380758, 60384325, 60490383, 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61064207, 61064208, 61090794, 61090795, 61097033, 61097034, 61100566, 61100567, 61100574, 61105891, 61105897, 61113639, 61113645, 61113646, 61116566, 61121505, 61121506, 61128967, 61128968, 61133861, 61138439, 61138442, 61138443, 61154231, 61154232, 61154233, 61158301, 61158302, 61158303, 61170875, 61170879, 61170880, 61174194, 61174195, 61174196, 61181646, 61181647, 61187787, 61187788, 61193867, 61193868, 61193869, 61204960, 61204961, 61211005, 61211006, 61216059, 61216061, 61216062, 61221205, 61221210, 61221211, 61225959, 61225960, 61231008, 61235899, 61235901, 61240547, 61240553, 61240554, 61245334, 61245339, 61248772, 61253726, 61253727, 61253728, 61253740, 61253741, 61259038, 61259050, 61259051, 61259052, 61262912, 61262913, 61262914, 61267831, 61267832, 61267833, 61272589, 61272591, 61272592, 61277576, 61277579, 61277581, 61277593, 61277594, 61280567, 61280568, 61280569, 61280570, 61285881, 61285882, 61285883, 61285884, 61289979, 61289983, 61289984, 61289985, 61289986, 61295477, 61295478, 61295479, 61295492, 61295493, 61295494, 61295495, 61298641, 61298642, 61298643, 61298644, 61302111, 61302112, 61302113, 61302123, 61302124, 61307077, 61307078, 61307091, 61307092, 61307093, 61307094, 61311104, 61311105, 61311106, 61311107, 61315695, 61315696, 61315697, 61315698, 61319841, 61319842, 61319843, 61319855, 61319856, 61319857, 61324498, 61324499, 61329235, 61329236, 61329237, 61329238, 61329239, 61329240, 61334549, 61334550, 61334551, 61334552, 61338275, 61338277, 61338278, 61338280, 61344113, 61344114, 61344115, 61344116, 61344117, 61344118, 61350325, 61350326, 61350327, 61350328, 61350329, 61350330, 61355751, 61355752, 61360850, 61360851, 61360852, 61360853, 61360866, 61365239, 61365240, 61365241, 61365242, 61365252, 61370242, 61370243, 61370248, 61370254, 61376582, 61376583, 61376593, 61376594, 61380427, 61380428, 61380429, 61386654, 61386655, 61386656, 61386657, 61386658, 61390834, 61390835, 61390836, 61390837, 61397690, 61397691, 61397692, 61399708, 61399709, 61410282, 61410283, 61410284, 61410285, 61412375 and 61412376.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    103594, 106289, 106292, 111085, 7878942, 7878943, 7879193, 7879545, 7883402, 7885282, 60218032, 60232197, 60237944, 60242849, 60251630, 60251631, 60256227, 60256228, 60258861, 60258862, 60258866, 60260765, 60260766, 60260771, 60264878, 60264879, 60264885, 60264887, 60267801, 60269821, 60269822, 60269823, 60273908, 60273909, 60296122, 60299532, 60299533, 60299537, 60302290, 60302291, 60307223, 60312263, 60312264, 60315646, 60315647, 60315648, 60317611, 60321952, 60321953, 60326189, 60326190, 60328165, 60328166, 60328167, 60331394, 60334529, 60334530, 60336057, 60336058, 60336059, 60339644, 60339645, 60350414, 60352912, 60352916, 60355709, 60355710, 60358833, 60358834, 60362091, 60362092, 60365654, 60365655, 60366475, 60369196, 60369200, 60372791, 60374332, 60374333, 60374334, 60374341, 60380759, 60380760, 60384326, 60492611, 60497693, 60502853, 60509189, 60512208, 60518613, 60526391, 60526392, 60528087, 60534174, 60538372, 60538373, 60542941, 60548471, 60553226, 60553227, 60553228, 60553229, 60555003, 60558664, 60558665, 60562937, 60562940, 60566979, 60566983, 60570905, 60575476, 60578774, 60578775, 60582742, 60584743, 60584744, 60584751, 60593844, 60595801, 60595802, 60595806, 60599413, 60608106, 60612404, 60616290, 60621127, 60621128, 60625485, 60627678, 60627686, 60631137, 60631138, 60634793, 60634794, 60644380, 60644381, 60649155, 60649156, 60649165, 60660344, 60660345, 60662640, 60662641, 60667952, 60673751, 60677461, 60682188, 60686879, 60692580, 60692581, 60696171, 60701929, 60701930, 60706412, 60706417, 60711160, 60717985, 60722696, 60722697, 60727491, 60727492, 60732164, 60732165, 60748250, 60752976, 60756487, 60760513, 60760514, 60765128, 60770658, 60775803, 60775807, 60782868, 60782869, 60790428, 60790433, 60790434, 60801751, 60801752, 60805433, 60809062, 60816241, 60823407, 60831902, 60831903, 60836383, 60840794, 60847125, 60847126, 60854119, 60854128, 60854134, 60854135, 60873478, 60873479, 60881701, 60881702, 60895102, 60895111, 60895112, 60902937, 60909855, 60917512, 60923132, 60929870, 60934276, 60934283, 60942493, 60942496, 60955229, 60955230, 60959685, 60968002, 60968003, 60968013, 60969516, 60979133, 60979134, 60983705, 60987133, 60987137, 61000884, 61000892, 61006371, 61006372, 61013839, 61018487, 61018488, 61022803, 61034994, 61034995, 61035005, 61045018, 61050235, 61057520, 61064210, 61064211, 61090796, 61097036, 61097037, 61100568, 61100570, 61105892, 61105893, 61105898, 61116568, 61116569, 61116570, 61121507, 61121508, 61128970, 61128971, 61128972, 61133863, 61138440, 61138444, 61138445, 61154234, 61154235, 61164689, 61164694, 61164695, 61170882, 61170883, 61174197, 61174198, 61187790, 61187791, 61193870, 61198696, 61204962, 61204963, 61211008, 61216063, 61216064, 61221206, 61221212, 61231009, 61231010, 61235902, 61245332, 61248774, 61248775, 61253723, 61253729, 61253730, 61253731, 61259039, 61259040, 61259041, 61259053, 61259054, 61259061, 61262898, 61262916, 61262918, 61267820, 61267835, 61267836, 61267837, 61272593, 61272594, 61277583, 61277584, 61277585, 61277595, 61280556, 61280557, 61280571, 61280572, 61280573, 61285886, 61285887, 61289980, 61289988, 61289989, 61289990, 61289991, 61295480, 61295481, 61295496, 61295497, 61295498, 61295499, 61298645, 61298646, 61298647, 61307079, 61307080, 61307081, 61307095, 61311093, 61311094, 61311109, 61311110, 61311111, 61315699, 61315701, 61315702, 61319844, 61319845, 61319846, 61319858, 61324492, 61324502, 61324503, 61329247, 61329248, 61329249, 61329250, 61334554, 61334555, 61334556, 61338281, 61338282, 61338283, 61344119, 61344120, 61344121, 61350338, 61355740, 61360854, 61360855, 61360856, 61365243, 61365244, 61365245, 61370237, 61370244, 61370245, 61376577, 61376584, 61376585, 61380423, 61380430, 61380431, 61380432, 61386649, 61386650, 61386651, 61386652, 61386653, 61395045, 61395046, 61397693, 61397694 and 61412377.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of AZ, IL, IN, KY, MO, NE, NM, NY, OH, TX, VA, WA, and WI; and countries of Austria, Belgium, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, UK, Ausralia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, Tawain and Thailand.
  • 제품 설명
    NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN. || This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collage disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. NexGen TM Tibial Trays may be used with or without bone cement (biological fixation). NexGen MIS Tibial Components and MIS Modular Tibial Plates and Keels are intended for cemented use only.
  • Manufacturer
하나 더 5 건 더