510(k) K022622

CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P by Berkeley Advanced Biomaterials, Inc. — Product Code MQV

K022622 is an FDA 510(k) premarket notification submitted by Berkeley Advanced Biomaterials, Inc. for the device "CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P". The FDA issued a decision of Substantially Equivalent on January 9, 2003. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Berkeley Advanced Biomaterials, Inc. has at least 10 other 510(k) clearances on record.