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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, spine, plate, laminoplasty, metal
Regulation Description Spinal interlaminal fixation orthosis.
Definition This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.
Product CodeNQW
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
BLACKSTONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 3
Explanted 1
Fracture 1
Mechanical issue 1
Migration of device or device component 1
Difficult to position 1
Failure to Adhere or Bond 1
Total Device Problems 9

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