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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device plate, cranioplasty, preformed, alterable
Regulation Description Preformed alterable cranioplasty plate.
Product CodeGWO
Regulation Number 882.5320
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
KLS MARTIN GMBH + CO. KG
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
SYNTHES
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Slippage of device or device component 3
No Known Device Problem 3
Peeled 2
No Information 1
Failure to Adhere or Bond 1
Bent 1
Component missing 1
Implant breakage or physical damage 1
Device operates differently than expected 1
Total Device Problems 14

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 1 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 Biomet Microfixation, LLC II Oct-20-2015
2 Respironics, Inc. II Apr-24-2008

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