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Axya Medical, Inc.
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MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 is an FDA 510(k)-cleared medical device (K011912) manufactured by Axya Medical, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 30, 2001. Regulation: 8.