Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
173
Total
162
Cleared
0
Denied
173 devices
Cleared
Oct 04, 2018
POWEREASE System
Neurology
27d
Cleared
Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
Orthopedic
124d
Cleared
Aug 29, 2018
CD HORIZON™ Spinal System
Orthopedic
23d
Cleared
May 18, 2018
KYPHON HV-R Bone Cement
Orthopedic
63d
Cleared
May 17, 2018
Navigated INFINITY Instruments
Orthopedic
20d
Cleared
Apr 18, 2018
VERTEX™ Reconstruction System
Orthopedic
16d
Cleared
Mar 08, 2018
CD HORIZON™ Spinal System
Orthopedic
149d
Cleared
Jan 18, 2018
Navigated INFINITY™ Instruments
Orthopedic
87d
Cleared
Nov 02, 2017
SOVEREIGN™ Spinal System
Orthopedic
92d
Cleared
Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
Orthopedic
120d
Cleared
Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
Orthopedic
165d
Cleared
Aug 21, 2017
INFINITY™ OCT System
Orthopedic
263d
Cleared
May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
Orthopedic
284d
Cleared
May 16, 2017
TRANSLACE™ Spinal Tethering System
Orthopedic
183d
Cleared
Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
Orthopedic
115d
Cleared
Feb 23, 2017
Medtronic Transportation/Sterilization Cassettes
General Hospital
94d
Cleared
Dec 20, 2016
CD HORIZON® Spinal System
Orthopedic
28d
Cleared
Dec 14, 2016
SOVEREIGN® Spinal System
Orthopedic
79d
Cleared
Nov 16, 2016
CD HORIZON® Spinal System
Orthopedic
84d
Cleared
Oct 04, 2016
CD HORIZON® Spinal System
Orthopedic
27d
Cleared
Mar 28, 2016
ANATOMIC PEEK PTC Cervical Fusion System
Orthopedic
32d
Cleared
Mar 07, 2016
PERIMETER Interbody Fusion Device
Orthopedic
20d
Cleared
Mar 02, 2016
PERIMETER C (Titanium) Spinal System
Orthopedic
96d
Cleared
Feb 18, 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for...
Orthopedic
83d
Cleared
Feb 10, 2016
CD HORIZON Spinal System
Orthopedic
56d
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