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Stryker Spine
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AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX is an FDA 510(k)-cleared medical device (K100865) manufactured by Stryker Spine. 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 10, 2010. Regulation: 8.