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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device manual instruments designed for use with non-fusion spinous process tension band implant
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process tension band implant for non-fusion use.
Product CodeSGL
Regulation Number 888.4520
Device Class 2


Premarket Reviews
ManufacturerDecision
EMPIRICAL SPINE
  SUBSTANTIALLY EQUIVALENT 1

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