510(k) K243706

Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules by Medtronic Sofamor Danek, Inc. — Product Code MQV

K243706 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek, Inc. for the device "Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Medtronic Sofamor Danek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2025
Date Received
November 29, 2024
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