
Sofamor Danek Mfg., Inc.
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RESORABPLUG is an FDA 510(k)-cleared medical device (K920118) manufactured by Sofamor Danek Mfg., Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1993. Regulation: 8.