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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, knee, femorotibial, semi-constrained, cemented, trunnion-bearing
Regulation Description Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
Product CodeLGE
Regulation Number 888.3530
Device Class 2


Premarket Reviews
ManufacturerDecision
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
No Information 1
Total Device Problems 2

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