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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plate, bone
Regulation Description Bone plate.
Product CodeJEY
Regulation Number 872.4760
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 1
FAICO MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 2
MEDCAD
  SUBSTANTIALLY EQUIVALENT 2
METICULY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MONTJADE ENGINEERING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REOSS GMBH
  SUBSTANTIALLY EQUIVALENT 1
SITES MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K202918  OsteoSync™ Ti Dental Mesh
STRYKER
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CRANIOMAXILLOFACIAL
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CRANIOMAXILLOFACIAL (CMF)
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 3
STRYKER LEIBINGER MICRO IMPLANTS
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TECHMAH CMF
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Materialise N.V. II Aug-03-2023
3 Materialise N.V. II Apr-06-2020
4 Synthes Produktions GmbH II Jul-30-2020
5 Synthes, Inc. II Jul-24-2020
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