510(k) K051951

CERAMENT BONE VOID FILLER by Bonesupport AB — Product Code MQV

K051951 is an FDA 510(k) premarket notification submitted by Bonesupport AB for the device "CERAMENT BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on September 28, 2005. 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
September 28, 2005
Date Received
July 18, 2005
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