Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

440 results for "Medtronic Sofamor Danek"
49–72 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Sep 12, 2019
Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™...
K191148 · PML
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 135d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Jul 03, 2019
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K190959 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 82d
Cleared May 06, 2019
Capstone Control™ Spinal System
K190165 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 95d
Cleared Apr 04, 2019
PYRAMESH™ Implant System
K183197 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 136d
Cleared Feb 06, 2019
Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion...
K182885 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 114d
Cleared Jan 16, 2019
T2 STRATOSPHERE Expandable Corpectomy System
K183510 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jan 15, 2019
OsteoCool RF Ablation System
K182497 · GEI
Medtronic Sofamor Danek USA, Inc.
General & Plastic Surgery · 125d
Cleared Jan 11, 2019
CD Horizon™ Spinal System
K182928 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 81d
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Oct 04, 2018
POWEREASE System
K182436 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 27d
Cleared Sep 19, 2018
T2 STRATOSPHERE™ Expandable Corpectomy System
K181328 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 124d
Cleared Aug 29, 2018
CD HORIZON™ Spinal System
K182119 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 23d
Cleared May 18, 2018
KYPHON HV-R Bone Cement
K180700 · NDN
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Apr 18, 2018
VERTEX™ Reconstruction System
K180851 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Mar 08, 2018
CD HORIZON™ Spinal System
K173249 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 149d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Dec 20, 2017
T2 STRATOSPHERE™ Expandable Corpectomy System
K173125 · MQP
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Nov 02, 2017
SOVEREIGN™ Spinal System
K172328 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 92d
Cleared Oct 05, 2017
ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal...
K171689 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Sep 26, 2017
CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System
K171107 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Sep 19, 2017
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System,...
K172199 · MAX
Medtronic Sofamor Danek
Orthopedic · 60d
Cleared Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d