
Spine Vision, Inc.
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P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM) is an FDA 510(k)-cleared medical device (K013312) manufactured by Spine Vision, 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 February 12, 2002. Regulation: 8.