FDA 510(k) Application Details - K121115

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K121115
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo, CA 93012 US Other 510(k) Applications for this Company
Contact	ADAM GROSS Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2012
Decision Date	07/18/2012
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