FDA 510(k) Application Details - K091994

Device Classification Name	Orthosis, Spine, Plate, Laminoplasty, Metal   More FDA Info for this Device
510(K) Number	K091994
Device Name	Orthosis, Spine, Plate, Laminoplasty, Metal
Applicant	DEPUY SPINE, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	DAPHNEY GERMAIN Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	NQW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2009
Decision Date	01/07/2010
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