FDA 510(k) Application Details - K121862

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K121862
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	DIO MEDICAL CO., LTD. 325 N. PUENTE ST UNIT B BREA, CA 92821 US Other 510(k) Applications for this Company
Contact	APRIL LEE Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/26/2012
Decision Date	10/31/2012
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