Atlas FDA

CD HORIZON SPINAL SYSTEM

FDA 510(k) clearance K060615 · decided 2006-10-25

Clearance details

K-number
K060615
Device name
CD HORIZON SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek
Decision
Substantially Equivalent
Date received
2006-03-07
Decision date
2006-10-25
Days to decision
232 days
Clearance type
Traditional
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Memphis, TN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1408-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1409-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1410-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1411-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1412-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1413-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1414-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1415-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1416-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1417-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1418-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1419-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1420-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1421-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1422-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1423-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1424-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1425-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1426-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1427-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1428-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1429-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1430-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1431-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1432-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1433-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1434-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1435-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1436-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1437-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1438-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1439-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1440-2008)Medtronic Sofamor Danek USA Inc2008-09-11
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, recall (Z-1441-2008)Medtronic Sofamor Danek USA Inc2008-09-11