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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, subtalar, plug, polymer
Regulation Description Smooth or threaded metallic bone fixation fastener.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeMJW
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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