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FDA Approves First Prosthetic Implant for Above-Knee Amputees


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The OPRA Implant System has been on the market under a humanitarian device exemption since 2015 and is now fully approved by FDA for patients who have trouble with conventional socket prosthetics.
FDA approved the first implant system for adults who have above-the-knee amputations and might not be able to use a conventional socket prosthetic device.
The Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, has been on the U.S. market since 2015 under a humanitarian device exemption, and FDA blessed the prosthetic device with a pre-market approval in late December. The approval expands options for people with above-the-knee amputations and can help those who have had or may have problems with rehabilitation and have not been able to benefit from available socket prostheses, according to Capt. Raquel Peat, PhD, director of FDA s Center for Devices and Radiological Health s Office of Ortho ....

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FDA approves implant system for transfemoral amputations

FDA approves implant system for transfemoral amputations
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Drug Administration , Osseoanchored Prostheses , Implant System , Transfemoral Amputation , Premarket Approval , உள்வைப்பு அமைப்பு ,