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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, eye sphere
Product CodeHPZ
Regulation Number 886.3320
Device Class 2


Premarket Reviews
ManufacturerDecision
CERAMISYS LTD.
  SUBSTANTIALLY EQUIVALENT 1
EVERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FCI (FRANCE CHIRURGIE INSTRUMENTATION) SAS
  SUBSTANTIALLY EQUIVALENT 1
OCULO PLASTIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
OCULO-PLASTIK, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRODUCT AND EDUCATIONAL SERVICES LLC
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial II Apr-18-2012
2 Integrated Orbital Implants Inc II Jun-22-2011
3 Integrated Orbital Implants Inc III Aug-26-2010
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