Devices

Device Recall MAXIMIS Pedicle Screw Spinal Fixation System

  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 0703-0019; no known Lot No.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS Marking Pin (Round Jaw). Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
  • 1 Event

제조사

Valorem Surgical LLC
  • 제조사 주소
    Valorem Surgical LLC, 3963 W Belmont Ave Ste 9, Chicago IL 60618-5129
  • Source
    USFDA

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Device Recall MAXIMIS Pedicle Screw Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 0703-0012; Known Lot No. WNV101203, WNV111130.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS Rod Holder. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
Device Recall MAXIMIS Pedicle Screw Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. SR60-350; Known Lot No. NHS160219.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 350 Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
Device Recall MAXIMIS Pedicle Screw Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. SR60-400; Known Lot No. NHS160219.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 400mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
Device Recall MAXIMIS Pedicle Screw Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. SR60-500; Known Lot No. NHS160219.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 500mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
Device Recall MAXIMIS Pedicle Screw Spinal Fixation System
  • 모델명 / 제조번호(시리얼번호)
    Catalog No. 0703-0001; Known Lot No. WNV101126.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS Awl. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. || Intended for posterior pedicle screw fixation of the non-cervical spine.
  • Manufacturer
    Valorem Surgical LLC
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