510(k) K110003

MTF NEW BONE VOID FILLER by Musculoskeletal Transplant Foundation — Product Code MQV

K110003 is an FDA 510(k) premarket notification submitted by Musculoskeletal Transplant Foundation for the device "MTF NEW BONE VOID FILLER". The FDA issued a decision of Substantially Equivalent on October 13, 2011. 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
October 13, 2011
Date Received
January 3, 2011
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