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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pin, fixation, resorbable, hard tissue
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Product CodeOVZ
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 4
Component Missing 2
Pin 1
Difficult or Delayed Positioning 1
Migration or Expulsion of Device 1
Material Integrity Problem 1
Total Device Problems 10


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