FDA 510(k) Application Details - K150200

Device Classification Name

  More FDA Info for this Device
510(K) Number K150200
Device Name CD HORIZON Growth Rod Conversion Set
Applicant MEDTRONIC SOFAMOR DANEK USA, INCORPORATED
1800 PYRAMID PLACE
MEMPHIS, TN 38132-3576 US
Other 510(k) Applications for this Company
Contact LEE GRANT
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 01/29/2015
Decision Date 02/25/2015
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