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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hook, bone
Regulation Description Manual surgical instrument for general use.
Product CodeKIK
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Crack 1
Mechanical issue 1
Total Device Problems 4

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