CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ

CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ is an FDA 510(k)-cleared medical device (K030266) manufactured by Berkeley Advanced Biomaterials, 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 February 19, 2003. Regulation: 8.