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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, ankle, semi-constrained, cemented, metal/composite
Regulation Description Ankle joint metal/composite semi-constrained cemented prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKMD
Premarket Review Joint Arthroplasty Devices (DHT6A)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3100
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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