FDA 510(k) Application Details - K953915

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K953915
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	DEPUY, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	CHERYL HASTINGS Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/1995
Decision Date	02/15/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review