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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device methyl methacrylate for cranioplasty
Regulation Description Methyl methacrylate for cranioplasty.
Product CodeGXP
Regulation Number 882.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 4
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
ETEX CORP.
  SUBSTANTIALLY EQUIVALENT 2
IMMEDICA INC.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOGENICS BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PARALLAX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
POREX SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Other (for use when an appropriate device code cannot be identified) 3
Implant, removal of 2
Device remains implanted 2
Device, or device fragments remain in patient 2
Loss of or failure to bond 1
Coagulation in device or device ingredient 1
Crack 1
Device Issue 1
Defective item 1
Device operates differently than expected 1
Foreign material present in device 1
No Known Device Problem 1
Total Device Problems 17

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 1 0 0 2 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Doctor's Research Group, Inc. II May-08-2012
2 OSTEOPORE INTERNATIONAL PTE LTD II Jan-11-2012
3 Stryker Craniomaxillofacial Division II Aug-26-2013
4 Synthes USA (HQ), Inc. II Nov-16-2009

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