FDA 510(k) Application Details - K102323

Device Classification Name	More FDA Info for this Device
510(K) Number	K102323
Device Name	CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
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	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/17/2010
Decision Date	12/16/2010
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