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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device brace, drill
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXY
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Loose 1
Device Issue 1
Total Device Problems 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Musculoskeletal Transplant Foundation, Inc. II Jul-15-2015

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