FDA 510(k) Application Details - K100354

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K100354
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	OSTEOMED L.P. 8202 SHERMAN RD CHESTERLAND, OH 44026-2141 US Other 510(k) Applications for this Company
Contact	KAREN E WARDEN 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	02/12/2010
Decision Date	08/17/2010
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