
Biomet Spine
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SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM is an FDA 510(k)-cleared medical device (K093629) manufactured by Biomet 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 March 8, 2010. Regulation: 8.