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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 spacer devices
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.
Product CodeQLR
Regulation Number 888.4520
Device Class 2


Premarket Reviews
ManufacturerDecision
COMPANION SPINE FRANCE
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Wright Medical Technology, Inc. II Jul-12-2022
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