
Unitedstates Surgical
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MODIFICATION TO SPIRAL RADIUS 90-D SST SYSTEM is an FDA 510(k)-cleared medical device (K021825) manufactured by Unitedstates Surgical. 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 30, 2002. Regulation: 8.