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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, finger, constrained, polymer
Regulation Description Finger joint polymer constrained prosthesis.
Product CodeKYJ
Regulation Number 888.3230
Device Class 2


Premarket Reviews
ManufacturerDecision
ASCENSION ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AVANTA
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 30
Implant, removal of 29
Break 13
Component(s), broken 5
Component(s), worn 2
Loose or intermittent connection 2
Product quality issue 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Dislodged or dislocated 1
Incorrect device or component shipped 1
Item contaminated during manufacturing or shipping 1
No Information 1
Total Device Problems 88

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