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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device motor, surgical instrument, pneumatic powered
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGET
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Information 1
Total Device Problems 1

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. II Jan-15-2009

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