
Biocompatibles, Inc.
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SYNTHETIC SEEDING SPACER MODEL SS9 X 50-50, SS9 X 55-50, SS9 X 55-150, SS9 X 1CM-30 is an FDA 510(k)-cleared medical device (K100847) manufactured by Biocompatibles, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 2010. Regulation: 8.