FDA 510(k) Application Details - K103137

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

  More FDA Info for this Device
510(K) Number K103137
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant VERTICOR, LTD
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
Other 510(k) Applications for this Company
Contact J.D. WEBB
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 10/25/2010
Decision Date 02/10/2011
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



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