FDA 510(k) Application Details - K993503

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K993503
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. 200 GREGORY LN. SUITE C-100 PLEASANT HILL, CA 94523 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF 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	10/15/1999
Decision Date	04/14/2000
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