FDA 510(k) Application Details - K081414

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K081414
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	THEKEN SPINE LLC 1800 TRIPLETT BLVD. AKRON, OH 44306 US Other 510(k) Applications for this Company
Contact	DALE DAVISON Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2008
Decision Date	06/17/2008
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