Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Growing Rod System
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
Applicant Contact LEE GRANT
Correspondent
Medtronic Sofamor Danek USA, Incorporated
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact LEE GRANT
Regulation Number888.3070
Classification Product Code
PGM  
Date Received01/29/2015
Decision Date 02/25/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-