FDA 510(k) Application Details - K170953

Device Classification Name

  More FDA Info for this Device
510(K) Number K170953
Device Name Tomcat Cervical Spinal System
Applicant Choice Spine, LP
400 Erin Drive
Knoxville, TN 37919 US
Other 510(k) Applications for this Company
Contact Kim Finch
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 03/31/2017
Decision Date 04/21/2017
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