FDA 510(k) Application Details - K993513

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K993513
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	ALPHATEC MFG., INC. 42-160 STATE ST. PALM DESERT, CA 92211-5148 US Other 510(k) Applications for this Company
Contact	JASON BLAIN 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	10/18/1999
Decision Date	04/26/2000
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