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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone fixation cerclage, sublaminar
Regulation Description Bone fixation cerclage.
Definition Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.
Product CodeOWI
Regulation Number 888.3010
Device Class 2


Premarket Reviews
ManufacturerDecision
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 1
Fracture 1
Total Device Problems 2

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