510(k) K040669

CERAFORM BONE VOID FILLER by Teknimed, S.A. — Product Code MQV

K040669 is an FDA 510(k) premarket notification submitted by Teknimed, S.A. for the device "CERAFORM BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on May 3, 2004. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Teknimed, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2004
Date Received
March 15, 2004
Clearance Type
Special
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