FDA 510(k) Application Details - K093491

Device Classification Name	More FDA Info for this Device
510(K) Number	K093491
Device Name	HIP SEXTANT INSTRUMENT SYSTEM
Applicant	SURGICAL PLANNING ASSOCIATES 80 SHELTON TECHNOLOGY CENTER MEDFORD, MA 02155 US Other 510(k) Applications for this Company
Contact	JOSEPH AZARY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/10/2009
Decision Date	12/09/2010
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