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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, total talus replacement, metal
Definition Replaces the native talus
Physical State Solid metallic device that is free-floating (not fixed to any bone or soft tissue)
Technical Method Placed between the distal tibia and calcaneus
Target Area Talus
Review Panel Orthopedic
Product CodeQNN
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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