FDA 510(k) Application Details - K090474

Device Classification Name	Intraoperative Orthopedic Joint Assessment Aid   More FDA Info for this Device
510(K) Number	K090474
Device Name	Intraoperative Orthopedic Joint Assessment Aid
Applicant	ORTHOSENSOR, INC. 962 ALLEGRO LN. APOLLO BEACH, FL 33572 US Other 510(k) Applications for this Company
Contact	JON WARD 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	02/24/2009
Decision Date	10/19/2009
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