FDA 510(k) Application Details - K041616

Device Classification Name	Filler, Bone Void, Calcium Compound   More FDA Info for this Device
510(K) Number	K041616
Device Name	Filler, Bone Void, Calcium Compound
Applicant	ORTHOS (UK) LIMITED THE STABLES, LEIGH COURT ABBOTS LEIGH BRISTOL NORTH SOMERSET BS8 3RA GB Other 510(k) Applications for this Company
Contact	ALAN RORKE 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	06/15/2004
Decision Date	08/25/2004
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