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U.S. Department of Health and Human Services

Product Classification

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Device nail, fixation, bone, metallic
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNDH
Premarket Review Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
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
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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