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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthosis, cervical pedicle screw spinal fixation
Definition This device is a posterior pedicle screw fixation system indicated for any of the following: Cervical spondylolisthesis (all grades and types) cervical spondylosis cervical degenerative disc disease degeneration of the cervical facets accompanied by instability cervical trauma (fracture dislocation) revision of failed previous fusion surgery (pseudoarthrosis) of the cervical spine
Product CodeNKG
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Fracture 1
Total Device Problems 2

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