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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device absorbable metallic bone fixation fastener
Definition An absorbable metallic bone fixation fastener is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after steosynthesis is achieved.
Product CodeQJD
Regulation Number 888.3041
Device Class 2


Premarket Reviews
ManufacturerDecision
BIORETEC LTD.
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