BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT

BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT is an FDA 510(k)-cleared medical device (K971139) manufactured by Boston Scientific Corp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1997. Regulation: 8.