FDA 510(k) Application Details - K043308

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K043308
Device Name	Filler, Bone Void, Calcium Compound
Applicant	DEPUY SPINE, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	SHARON STAROWICZ 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	12/01/2004
Decision Date	02/16/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review