Alphatec Spine, Inc.

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 14 건

  • 모델명 / 제조번호(시리얼번호)
    Lot # 635436; Part #73601-110
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
  • 제품 설명
    ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 53298
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including states of TX, FL, & NJ.
  • 제품 설명
    ROC Lumbar bolt caddy, Part Number: 81997-01-05. || Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
  • 모델명 / 제조번호(시리얼번호)
    Part Number(s): 64817-010 Lot Number(s): 623549; Part Number(s): 64817-012 Lot Number(s): 623551; Part Number(s): 64817-013 Lot Number(s): 623552; Part Number(s): 64817-014 Lot Number(s): 623553; Part Number(s): 64817-107 Lot Number(s): 623584; Part Number(s): 64113-012 Lot Number(s): 623619; Part Number(s): 64113-010 Lot Number(s): 623620; Part Number(s): 64765-109 Lot Number(s): 623909; and Part Number(s): 64733-124 Lot Number(s): 623778.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- CA, NV, FL, CT, TX, IA and WI.
  • 제품 설명
    Alphatec Spine, Inc., NOVEL SPINAL SPACER SYSTEM, Part Number(s): 64817-010, 64817-012, 64817-013, 64817-014, 64817-107, 64113-012, 64113-010, 64765-109, 64733-124. || Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology.
  • 모델명 / 제조번호(시리얼번호)
    Product code KWQ. 510(k) K102820 Part Number 71721. Lot numbers: 6629701, 6594701, 6434301, 6434302, 6434302R1.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. || The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bone screws to provide the versatility required for the specific indications noted. Fixation is achieved by means of a rigid plate that is surgically attached to the spine with bone screws. The TRESTLE LUXE Anterior Cervical Plating System is intended for use in the anterior cervical spine (C2-C7). Patients with trauma (including fractures), spondylolisthesis, and pseudoarthrosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, tumors, and failed previous fusion.
  • 모델명 / 제조번호(시리얼번호)
    Lot No. 7117902
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including CT, NC, AL, WV, IL, AR, and NY.
  • 제품 설명
    Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3).
하나 더 9 건 더

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Alphatec Spine, Inc., 5830 El Camino Real, Carlsbad CA 92008-8816
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • 제조사 모회사 (2017)
  • Source
    USFDA
  • 제조사 주소
    Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad CA 92008
  • 제조사 모회사 (2017)
  • Source
    USFDA