Here are four key notes, according to the report:
1. The new device uses an external prosthetic limb, which attaches to a fixture implanted in the patient’s thigh bone.
2. According to an FDA release, there was a need for OPRA because not every patient with an above-the-knee amputation is a candidate for a prosthetic limb that connects to a custom socket.
3. Two surgical procedures are necessary to install the OPRA device.
4. The FDA approved the new prosthesis through its humanitarian device exemption pathway, according to the report.
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25 spine devices receive FDA 510(k) clearance in June
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