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U.S. Department of Health and Human Services

Product Classification

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Device software for diagnosis/treatment
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions
Physical State Custom written or off the shelf software intended to be used with an orthopedic trauma device
Technical Method Software operated by the manufacturer or end user intended to diagnose or treat an orthopedic condition
Target Area Musculoskeletal system
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOSN
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible