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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, toe (metatarsophalangeal), joint, metal/polymer, semi-constrained
Product CodeLZJ
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
DOW
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
KINETIKOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC BIOSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1

Device Problems
Unknown (for use when the device problem is not known) 1
Total Device Problems 1

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