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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, wrist, carpal scaphoid
Regulation Description Wrist joint carpal scaphoid polymer prosthesis.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeKWO
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 888.3760
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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