
Centerpulse Spine-Tech, Inc.
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CENTERPULSE, SPINE-TECH DIVISION CEMENT RESTRICTOR is an FDA 510(k)-cleared medical device (K022615) manufactured by Centerpulse Spine-Tech, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 28, 2002. Regulation: 8.