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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bur, surgical, general & plastic surgery
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFF
Regulation Number 878.4820
Device Class 1


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KOMET MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIRE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THE ANSPACH EFFORT, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Overheating of device or device component 2
Total Device Problems 2

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

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. II Apr-08-2008
2 Sterilmed Inc II Jan-13-2009

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