
Vertiflex, Inc.
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OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM is an FDA 510(k)-cleared medical device (K082270) manufactured by Vertiflex, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 15, 2008. Regulation: 8.