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U.S. Department of Health and Human Services

Product Classification
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Device osseoanchored prostheses for the rehabilitation of transfemoral amputees
Definition The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
Physical State The device may be threaded, or coated to provide fixation to the bone. The device is made from medical grade metallic components.
Technical Method The device is implanted into the femur to allow a fixation point for standard prosthetic limbs.
Target Area Femur of amputee patients.
Review Panel Orthopedic
Product CodePJY
Premarket Review Office of Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type PMA
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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