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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, chin, internal
Regulation Description Chin prosthesis.
Product CodeFWP
Regulation Number 878.3550
Device Class 2


Premarket Reviews
ManufacturerDecision
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
CUI CORP.
  SUBSTANTIALLY EQUIVALENT 2
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTECH ASSOCIATES INC.
  1
  SUBSTANTIALLY EQUIVALENT 13
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
S. JACKSON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SILIMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1
  2

Device Problems
No Known Device Problem 3
Electro-magnetic interference (EMI) 2
Total Device Problems 5

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

Recalls
Manufacturer Recall Class Date Posted
1 Implantech Associates Inc II Sep-17-2013
2 Stryker Craniomaxillofacial Division II Feb-11-2015

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