510(k) K053218

DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX by Musculoskeletal Transplant Foundation — Product Code MQV

K053218 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "DBX DEMINERALIZED BONE MATRIX PUTTY/PASTE/MIX". The FDA issued a decision of Substantially Equivalent on December 28, 2006. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Musculoskeletal Transplant Foundation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2006
Date Received
November 17, 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