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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device splint, hand, and components
Regulation Description Limb orthosis.
Product CodeILH
Regulation Number 890.3475
Device Class 1


Premarket Reviews
ManufacturerDecision
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 2
Foreign material present in device 1
Not Applicable 1
Material rupture 1
Total Device Problems 5

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