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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ankle fusion cage
Regulation Description Intramedullary fixation rod.
Definition Intended for use as an accessory to a tibiotalocalcaneal Intramedullary (IM) rod as part of a fusion construct for failed ankle arthrodesis or failed ankle arthroplasty. Not intended for standalone use.
Product CodeSAI
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D, INC.
  SUBSTANTIALLY EQUIVALENT 1

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