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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device implant, malar
Product CodeLZK
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CUI CORP.
  SUBSTANTIALLY EQUIVALENT 2
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 11
LIFECORE BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SILIMED
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 5
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 1 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Spectrum Designs Inc II Jun-25-2015
2 Spectrum Designs Inc II Aug-29-2007

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