FDA 510(k) Application Details - K081240

Device Classification Name	Arthroscope   More FDA Info for this Device
510(K) Number	K081240
Device Name	Arthroscope
Applicant	SPINAL DEVICES, LLC 13540 GUILD AVE APPLE VALLEY, MN 55124 US Other 510(k) Applications for this Company
Contact	RICHARD JANSEN Other 510(k) Applications for this Contact
Regulation Number	888.1100   More FDA Info for this Regulation Number
Classification Product Code	HRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2008
Decision Date	02/27/2009
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