FDA 510(k) Application Details - K012273

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K012273
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. NORWALK, CT 06856 US Other 510(k) Applications for this Company
Contact	JENNIFER SCHUCK 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	07/19/2001
Decision Date	08/15/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review