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U.S. Department of Health and Human Services

Product Classification

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Device rod, fixation, intramedullary and accessories
Regulation Description Intramedullary fixation rod.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeHSB
Premarket Review Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3020
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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