FDA 510(k) Application Details - K072729

Device Classification Name Appliance, Fixation, Spinal Interlaminal

  More FDA Info for this Device
510(K) Number K072729
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant SEASPINE, INC.
2302 LA MIRADA DR.
VISTA, CA 92081-7862 US
Other 510(k) Applications for this Company
Contact ETHEL BERNAL
Other 510(k) Applications for this Contact
Regulation Number 888.3050

  More FDA Info for this Regulation Number
Classification Product Code KWP
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 09/26/2007
Decision Date 04/17/2008
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



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