FDA 510(k) Application Details - K140331

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K140331
Device Name	Orthopedic Stereotaxic Instrument
Applicant	ORTHALIGN, INC 120 COLUMBIA SUITE 500 ALISO VIEJO, CA 92656 US Other 510(k) Applications for this Company
Contact	DAVID VANCELETTE Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	OLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2014
Decision Date	06/10/2014
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