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. CL60-100; 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 Large Crosslink. 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. CR60-030; Lot No. Unknown.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 5.5 x 05mm Curved 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. C060-050; Known Lot No. WNV110516
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 50mm Curved 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. C060-060; Known Lot No. WNV110516
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution - US including CA and VA.
  • 제품 설명
    PALLAS M/MAXIMIS 60mm Curved 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. 0902-1007. Unknown 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 5.5 mm Instrument Tap. 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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