FDA 510(k) Application Details - K121313

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K121313
Device Name	Filler, Bone Void, Calcium Compound
Applicant	MUSCULOSKELETAL TRANSPLANT FOUNDATION 125 MAY STREET EDISON, NJ 08837 US Other 510(k) Applications for this Company
Contact	NANCY JOY Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	MQV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/02/2012
Decision Date	01/11/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review