
Aesculap Implant Systems, Inc.
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AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE is an FDA 510(k)-cleared medical device (K071983) manufactured by Aesculap Implant Systems, 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 April 30, 2008. Regulation: 8.