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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State Smooth or threaded absorbable metallic bone fixation fastener, such as bone screws, pins and k-wires
Technical Method Connect bones or bone fragments providing stability for osteosynthesis.
Target Area Bone (fractured bone and osteotomy)
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQJD
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3041
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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