FDA 510(k) Application Details - K031423

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K031423
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	EBI, L.P. 399 JEFFERSON ROAD PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	JON CAPARETTA 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	05/06/2003
Decision Date	06/27/2003
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