FDA 510(k) Application Details - K081567

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

  More FDA Info for this Device
510(K) Number K081567
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant VERTEBRON, INC.
80 HATHAWAY DRIVE
STRATFORD, CT 06615 US
Other 510(k) Applications for this Company
Contact LUIS NESPRIDO
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 06/04/2008
Decision Date 07/03/2008
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact