Medtronic Sofamor Danek USA, Inc. - FDA 510(k) Cleared Devices
169
Total
158
Cleared
0
Denied
154 devices
Cleared
Jan 15, 2021
CD HORIZON™ Spinal System
Orthopedic
29d
Cleared
Dec 08, 2020
CD Horizon Spinal System Instruments
Orthopedic
29d
Cleared
Sep 10, 2020
CD Horizon™ Spinal System
Orthopedic
105d
Cleared
Sep 08, 2020
CD Horizon Spinal System
Orthopedic
22d
Cleared
Mar 23, 2020
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal...
Orthopedic
264d
Cleared
Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
Orthopedic
132d
Cleared
Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
Orthopedic
73d
Cleared
Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
Orthopedic
86d
Cleared
Oct 03, 2019
CD Horizon™ Astute™ Spinal System
Orthopedic
164d
Cleared
Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™...
Orthopedic
135d
Cleared
Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
Orthopedic
129d
Cleared
Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
Orthopedic
82d
Cleared
May 06, 2019
Capstone Control™ Spinal System
Orthopedic
95d
Cleared
Apr 04, 2019
PYRAMESH™ Implant System
Orthopedic
136d
Cleared
Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
Orthopedic
114d
Cleared
Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
Orthopedic
29d
Cleared
Jan 11, 2019
CD Horizon™ Spinal System
Orthopedic
81d
Cleared
Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
Orthopedic
88d
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
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