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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device device, fixation, proximal femoral, implant
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeJDO
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STELKAST
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Component(s), broken 3
Break 1
Cable break 1
Total Device Problems 5

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