Devices

NonLocking Screw

  • 모델명 / 제조번호(시리얼번호)
    (UDI)/Lot: a) (18056099645959) B1082246; b) (18056099645966) B1075836; c) (18056099645973) B1084806; d) (18056099645980) B1089892; e) (18056099645997) B1075845; f) (18056099646000) B1084797; g) (18056099646017) B1084792; h) (18056099646024) B1084799; i) (18056099646031) B1083858; j) (18056099646048) B1083859; k) (18056099646055) B1089891, B1195735; l) (18056099646062) B1195736, B1089882; m)(18056099646079) B1204992, B1083850; n) (18056099646086) B1083848, B1195699; o) (18056099646093) B1195732, B1089896; p) (18056099646109) B1204991, B1083642; q) (18056099646116) B1195739, B1083851; r) (18056099646123) B1204988, B1083637; s) (18056099646130) B1195733, B1089898; t) (18056099646147) B1195744, B1083838; u) (18056099646154) B1195730, B1071599, B1083853
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
  • 제품 설명
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010) || b) D 3.2MM X 12MM (002-D-32012) || c) D 3.2MM X 14MM (002-D-32014) || d) D 3.2MM X 16MM (002-D-32016) || e) D 3.2MM X 18MM (002-D-32018) || f) D 3.2MM X 20MM (002-D-32020) || g) D 3.2MM X 22MM (002-D-32022) || h) D 3.2MM X 24MM (002-D-32024) || i) D 3.2MM X 26MM (002-D-32026) || j) D 3.2MM X 28MM (002-D-32028) || k) D 3.2MM X 30MM (002-D-32030) || l) D 3.2MM X 32MM (002-D-32032) || m) D 3.2MM X 34MM (002-D-32034) || n) D 3.2MM X 36MM (002-D-32036) || o) D 3.2MM X 38MM (002-D-32038) || p) D 3.2MM X 40MM (002-D-32040) || q) D 3.2MM X 42MM (002-D-32042) || r) D 3.2MM X 44MM (002-D-32044) || s) D 3.2MM X 46MM (002-D-32046) || t) D 3.2MM X 48MM (002-D-32048) || u) D 3.2MM X 50MM (002-D-32050)
  • Manufacturer
    Orthofix, Inc
  • 1 Event

제조사

Orthofix, Inc
  • 제조사 주소
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • 제조사 모회사 (2017)
    Orthofix International Nv
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 6 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall FPS 35mm x 3.5 mm nonlocking screw
  • 모델명 / 제조번호(시리얼번호)
    Part number - OS326835 Lot number: 10100/269A12-68051
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Distribution
  • 제품 설명
    FPS 35mm x 3.5 mm non-locking screw
  • Manufacturer
    Ortho Solutions Inc
Device Recall NEO(R) NonLocking screws
  • 모델명 / 제조번호(시리얼번호)
    All batch numbers
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Diribution - US including Tennessee; Foreign - Italy, Portugal, Spain, Switzerland, UK, and France
  • 제품 설명
    Non-Locking screws in the following lengths: || (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 || (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 || (c) DRP 0.27 - 12 mm, REF W27 ST012 || (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 || (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 || (f) NEO(R) 0.27 - 18 mm, REF W27 ST018 || (f) DRP 0.27 - 18 mm, REF W27 ST018 || The NEOVIEW(R) Plating System is intended for fixation of intra-articular and extra-articular fractures of the distal radius and reconstruction of the distal radius. It is composed of a NEOVIEW" plate in PEEK and NE0411 screws in Ti6Al4V that are available in Locking or Non-Locking versions. The NEOVIEW411 Screw Set consists of a standard set of NE0411 screws with different lengths suitable for the implantation of a NEOVIEW9 plate for an average anatomy
  • Manufacturer
    In2Bones, SAS
Rival Reduce Kit Locking and NonLocking Screw
  • 모델명 / 제조번호(시리얼번호)
    UDI: 18056099648592,  B1115657,  B1107222,  B1107223
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
  • 제품 설명
    Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C
  • Manufacturer
    Orthofix, Inc
Rival View Kit Locking and NonLocking Screw
  • 모델명 / 제조번호(시리얼번호)
    UDI: 18056099648578, Lot: B1094193,  B1104809,  B1107372
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
  • 제품 설명
    Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C
  • Manufacturer
    Orthofix, Inc
NonLocking Screw
  • 모델명 / 제조번호(시리얼번호)
    (UDI)/Lot: a) (18056099645614) B1204542, B1101808;  b) (18056099645621) B1204969, B1201169, B1075101;  c) (18056099645638) B1204554, B1195701, B1075428;  d) (18056099645645) B1204971, B1201176, B1075846;  e) (18056099645652) B1195727, B1204266, B1075426;  f) (18056099645669) B1204540, B1075429;  g) (18056099645676) B1204541, B1075425;  h) (18056099645683) B1204539, B1075177;  i) (18056099645690) B1204972, B1195700, B1075847;  j) (18056099645706) B1204555, B1195702, B1075427;  k) (18056099645713) B1204973, B1201170, B1075430;  l) (18056099645720) B1075825, B1201166, B1204270
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    U.S Consignees: NJ, FL, PA, SC, LA, VA, MN, TX, GA, DC, NV, IN, CA, MI, IL, MD, NC, OH, OK,
  • 제품 설명
    Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010); || c) D 2.0MM X 12MM (002-D-20012); || d) D 2.0MM X 14MM (002-D-20014); || e) D 2.0MM X 16MM (002-D-20016); || f) D 2.0MM X 18MM (002-D-20018); || g) D 2.0MM X 20MM (002-D-20020); || h) D 2.0MM X 22MM (002-D-20022); || i) D 2.0MM X 24MM (002-D-20024); || j) D 2.0MM X 26MM (002-D-20026); || k) D 2.0MM X 28MM (002-D-20028); || l) D 2.0MM X 30MM (002-D-20030)
  • Manufacturer
    Orthofix, Inc
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