FDA 510(k) Application Details - K982987

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K982987
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	JONATHAN M GILBERT Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/1998
Decision Date	10/21/1998
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