
Synthes (USA) Products, LLC
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DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) is an FDA 510(k)-cleared medical device (K201944) manufactured by Synthes (USA) Products, LLC. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 9, 2020. Regulation: 8.