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Signus Medizintechnik GmbH
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RABEA SPINAL IMPLANT is an FDA 510(k)-cleared medical device (K043316) manufactured by Signus Medizintechnik GmbH. 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 6, 2005. Regulation: 8.