510(k) K073316

CERAMENT BONE VOID FILLER, MODEL A0210 by Bonesupport AB — Product Code MQV

K073316 is an FDA 510(k) premarket notification submitted by Bonesupport AB for the device "CERAMENT BONE VOID FILLER, MODEL A0210". The FDA issued a decision of Substantially Equivalent on June 20, 2008. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Bonesupport AB has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2008
Date Received
November 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type