
Stryker Leibinger
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NON-INVASIVE PATIENT FIXATION SYSTEM is an FDA 510(k)-cleared medical device (K023449) manufactured by Stryker Leibinger. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 12, 2003. Regulation: 8.