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Advanced Bio-Surfaces, Inc.
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ORTHOGLIDE MEDICAL KNEE IMPLANT AND INSTRUMENTS, MODELS 9063, 9064, 9065, 9060, 9062, 9057, 9056 is an FDA 510(k)-cleared medical device (K053094) manufactured by Advanced Bio-Surfaces, 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 February 5, 2006. Regulation: 8.