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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device spinous process plate
Regulation Description Spinal interlaminal fixation orthosis.
Definition A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Product CodePEK
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to Adhere or Bond 2
Total Device Problems 2

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