Medical Device Manufacturer · US , Memphis , TN

Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices

169 submissions · 158 cleared · Since 2000
169
Total
158
Cleared
0
Denied
154 devices
51-75 of 154
Cleared Nov 02, 2017
SOVEREIGN™ Spinal System
K172328 · OVD
Orthopedic · 92d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K171689 · MAX
Orthopedic · 120d
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Orthopedic · 165d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Orthopedic · 263d
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · MAX
Orthopedic · 284d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Orthopedic · 183d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Orthopedic · 115d
Cleared Dec 20, 2016
CD HORIZON® Spinal System
K163301 · NKB
Orthopedic · 28d
Cleared Dec 14, 2016
SOVEREIGN® Spinal System
K162680 · OVD
Orthopedic · 79d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379 · NKB
Orthopedic · 84d
Cleared Oct 04, 2016
CD HORIZON® Spinal System
K162494 · NKB
Orthopedic · 27d
Cleared Mar 28, 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · ODP
Orthopedic · 32d
Cleared Mar 07, 2016
PERIMETER Interbody Fusion Device
K160418 · MAX
Orthopedic · 20d
Cleared Mar 02, 2016
PERIMETER C (Titanium) Spinal System
K153438 · ODP
Orthopedic · 96d
Cleared Feb 18, 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for...
K153442 · NKB
Orthopedic · 83d
Cleared Feb 10, 2016
CD HORIZON Spinal System
K153589 · NKB
Orthopedic · 56d
Cleared Dec 30, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463 · NKB
Orthopedic · 29d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · MAX
Orthopedic · 93d
Cleared Nov 12, 2015
ATLANTIS Anterior Cervical Plate System
K152623 · KWQ
Orthopedic · 59d
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248 · NKB
Orthopedic · 87d
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338 · NKG
Orthopedic · 70d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457 · NKB
Orthopedic · 60d
Cleared Aug 14, 2015
MASTERGRAFT Contain
K151172 · MQV
Orthopedic · 105d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · MAX
Orthopedic · 100d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Orthopedic · 134d

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