FDA 510(k) Application Details - K101310

Device Classification Name	More FDA Info for this Device
510(K) Number	K101310
Device Name	VU APOD INTERVERTEBRAL BODY FUSION DEVICE
Applicant	THEKEN SPINE LLC 1331 H STREET NW, 12TH FLOOR WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	Glenn Stiegman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2010
Decision Date	09/02/2010
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