FDA 510(k) Application Details - K974213

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K974213
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	SHARON MURPHY 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	11/10/1997
Decision Date	02/04/1998
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