FDA 510(k) Application Details - K002858

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K002858
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH ALLENDALE, NJ 07401-1677 US Other 510(k) Applications for this Company
Contact	MARY-CATHERINE DILLON 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	09/13/2000
Decision Date	10/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review