Stelkast Co

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 13 건

  • 모델명 / 제조번호(시리얼번호)
    Part Number SC1439-0600 - Lot numbers 8257-062904, 14298-0922705, 1740-091007, 14298-092705, 2256-110299, 4844-010302, 5447-072902, 6790-070803, and 8257-062904; Part number SC1439-0700 - Lot numbers 8258-062904, 16935-103006, 17874-061307, 1883-091007, 10559-040105, 16298-042606, 16935-103006, 2257-031199, 4845-101801, 6573-060303, 10559-040105, and 16935-103006; Part number SC1439-0800 - Lot numbers 19636-103006, 17875-043007, 19889-060208, 15910-013006, 16936-103006, 17875-043007, 4048-020701, 4418-071901, 5973-091202, 9776-102704, and 16936-103006; Part number SC1439-0900 - Lot numbers 16937-092506, 16301-042606, 16937-092506, 17876-071707, 10560-040105, 16301-042606, 16937-092506, 3201-110399, 3791-092000, 4617-102401, 6791-070803, 8487-071204, 14989-101205, and 16937-092506; Part number SC1439-1000 - Lot numbers 17610-032207, 14990-101005, 16166-050906, 16166-052206, 16306-082106, 17610-032207, 5260-062702, 7340-011204, and 16306-082106; Part number SC1439-1125 - Lot numbers 16938-092906, 17729-031907, 19152-042908, 20652-101308, 14991-091405, 15913-011806, 16439-050406, 16938-092906, 17729-031907, 2261-110299, 6113-111102, 6177-010703, 7341-090203, 15913-011806, and 17729-031907; Part number SC1439-1250 - Lot numbers 16839-082106, 8003-052504, 16939-102306, 17730-031907, 10563-040505, 15911-013006, 16839-082106, 16939-102306, 4420-1000901, 5006-040402, 6793-060303, 8003-052504, 16839-082106, and 16939-102306; Part number SC1439-1375 - Lot numbers 17731-031907, 17731-031907, 20654-092208, 10172-120604, 10564-041205, 14993-092605, 15912-013006, 17731-031907, 3794-121300, 15912-013006, and 17731-031907; Part number SC1439 - Lot numbers 8025-052504, 19153-042908, 14299-092705, 1889-110299, 19153-042908, 5262-050202, 6306-021803, 8025-052504, 5262-050202, and 8025-052504;  Part number SC1439-1625 - Lot numbers 1749-110299, 17120-022707, 1749-032007, 1749-110299, 2265-091499, 17120-022707, and 1749-110299; Part number SC1439-1750 - Lot numbers 1750-110299, 1169-091007, 1169-120406, 1649-030707, 1649-081307, 1649-091007, 1750-091007, and 1750-110299.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- states of NC, TX, and WV.
  • 제품 설명
    Dual Taper Wedge Pressed Fit Femoral Component. || The Dual Taper Wedge is a single use device intended for pressed fit reconstruciton of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present.
  • 모델명 / 제조번호(시리얼번호)
    Part number SC1439-1000. Lot number 17877-071707 exp 7/2017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    USA distribution to dealers in TX and WV.
  • 제품 설명
    Stelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
  • 모델명 / 제조번호(시리얼번호)
    Part number SC1591-38. Lot number 19906-052008
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution --- including states of IA and WV.
  • 제품 설명
    Proven Cemented Semi-Constrained Total Knee. Part number SC1591. The size is 38 and the thickness is 10 mm. || The Proven Knee System is a single use device intended for cemented reconstruction of the femoral and/or tibial portion of severely disabled and/or painful knee joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis with or without varus, valgus or flexion deformities, and revision surgery provided that there is radiographic evidence of sufficient sound bone to seat the prosthesis.
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 14896-122005, 16042-010906, 16048-031406, 16056-031406, and 16157-031406.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
  • 제품 설명
    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 14894-122005, 16040-010906, 16054-031406, 17945-043007, and 17945-050107.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
  • 제품 설명
    StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317
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    RLMPH