
Stryker Corporation
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Stryker iVAS 13g Bone Biopsy Kit is an FDA 510(k)-cleared medical device (K180327) manufactured by Stryker Corporation. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 25, 2018. Regulation: 8.