
Teleflex Medical, LLC
Free shipping on orders over $99 · 30-day returns
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape is an FDA 510(k)-cleared medical device (K260775) manufactured by Teleflex Medical, 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 May 5, 2026. Regulation: 8.