
Rizzoli Ortopedica S.P.A.
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REL-K ARTIFICAL LIMB PROSTHESIS is an FDA 510(k)-cleared medical device (K101859) manufactured by Rizzoli Ortopedica S.P.A.. This device is classified under the Physical Medicine specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 12, 2010. Regulation: 8.