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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, tendon, passive
Regulation Description Passive tendon prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeHXA
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3025
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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