Porous Plasma Spray (PPS) Ringloc Acetabular System

  • 모델명 / 제조번호(시리얼번호)
    M105210, M181710, M211040, M582230, M618540, M618560 and M618570.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104148, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 26 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    M582210
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, sterile, REF 16-104146, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M011320, M011340, M020960, M105260, M361280, M379570, M379580, M482310, M482330, M482340, M583540, M618580, M618910, M815740, M815750, M857250, M888560, M888590, M971590, M971600 and M971680.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104150, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflamnmatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers M022740, M022750, M134000, M379640, M387770, M387780, M387800, M387810, M423630, M618930, M743160, M888610, M888620 and M988780.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, sterile, REF 16-104152, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿a¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers M059630, M065810, M065820, M074220, M082510, M082530, M181820, M387830, M387850, M387870, M423730, M482410, M592100, M592150, M743190, M903070, M903080, M903090, M971770 and M061150.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104154, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers M048180, M061180, M061190, M276160, M276170, M276180, M299730, M383260, M383290, M383300, M874150, M903110, M903160, M903180, M903190, M903200, M903220, M903230, and M048200.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of Australia, Netherlands and Japan.
  • 제품 설명
    Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, sterile, REF 16-104156, Biomet Orthopedics, Warsaw, IN. || Intended Use: The Porous Plasma Spray (PPS) Ringloc¿ Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty. Indications For Use: 1 . Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed.
  • Manufacturer
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