
Synthes (USA) Products, LLC
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DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio MR Conditional is an FDA 510(k)-cleared medical device (K183472) manufactured by Synthes (USA) Products, LLC. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 2019. Regulation: 8.