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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device washer, bolt nut
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeHTN
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 8
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LINVATEC
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS
  SUBSTANTIALLY EQUIVALENT 1
PIONEER
  SUBSTANTIALLY EQUIVALENT 2
SURGICRAFT CO.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 5
TRIAGE MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant, removal of 2
No Information 2
Loss of osseointegration 1
Malfunction 1
Break 1
Component(s), broken 1
Fracture 1
Device, or device fragments remain in patient 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 11

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