
Axya Medical, Inc.
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AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR is an FDA 510(k)-cleared medical device (K051250) 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 June 8, 2005. Regulation: 8.