
Bionx Implants, Inc.
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BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES is an FDA 510(k)-cleared medical device (K003756) manufactured by Bionx Implants, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 2001. Regulation: 8.