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
-
1 to 10 of 197 Results
ProductCode: KWP Applicant: MEDTRONIC SOFAMOR DANEK Decision Date To: 03/24/2023
 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
Results per Page
New Search  
Export all 197 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
510(K)
Number
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Decision
Date
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
infinity oct system Medtronic Sofamor Danek USA, Inc. K223764 01/11/2023
cd horizon™ astute™ spinal system; cd horizon™ growth rod conversion set; cd horizon™ spinal system; cd horizon™ fenestrated screw set; colorado 2™ spinal system; gdlh™ posterior spinal system; shilla™ growth guidance system; tenor™ spinal system Medtronic Sofamor Danek USA, Inc. K221646 10/04/2022
cd horizon spinal system Medtronic Sofamor Danek USA, Inc. K211958 07/21/2021
cd horizon™ spinal system Medtronic Sofamor Danek USA, INC. K203678 01/15/2021
cd horizon™ spinal system Medtronic Sofamor Danek USA, INC. K201407 09/10/2020
cd horizon spinal system Medtronic Sofamor Danek USA, Inc. K202328 09/08/2020
cd horizon™ astute™ spinal system Medtronic Sofamor Danek, USA Inc. K191066 10/03/2019
cd horizon™ spinal system Medtronic Sofamor Danek USA, Inc. K182928 01/11/2019
cd horizon™ spinal system Medtronic Sofamor Danek USA, Inc. K182119 08/29/2018
vertex™ reconstruction system Medtronic Sofamor Danek USA, Inc K180851 04/18/2018
-
-