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U.S. Department of Health and Human Services

Product Classification
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Device implant, cartilage, for articular cartilage repair
Review Panel Orthopedic
Product CodeNCO
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type Contact ODE
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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