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Device Name
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Applicant
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510(K) Number
|
Decision Date
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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.
|
K203678 |
01/15/2021
|
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 spire z spinal system
|
MEDTRONIC SOFAMOR DANEK
|
K123246 |
11/16/2012
|
cd horizon spinal system
|
MEDTRONIC SOFAMOR DANEK, INC.
|
K111510 |
09/15/2011
|
modification to:cd horizon spinal system
|
MEDTRONIC SOFAMOR DANEK USA, INC.
|
K092325 |
12/15/2009
|
modification to cd horizon spinal system
|
MEDTRONIC SOFAMOR DANEK USA, INC.
|
K091974 |
09/02/2009
|
cd horizon spinal system
|
MEDTRONIC SOFAMOR DANEK
|
K091442 |
07/15/2009
|
cd horizon spinal system
|
MEDTRONIC SOFAMOR DANEK
|
K082236 |
10/10/2008
|