FDA 510(k) Application Details - K070108

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K070108
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	SYNVASIVE TECHNOLOGY, INC. P.O. BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	ONN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/2007
Decision Date	04/04/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review