FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

174 results for "Medtronic Sofamor Danek USA, Inc."
49–72 of 174
Search insights Median review: 83d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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 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 Aug 21, 2017
INFINITY™ OCT System
K163375 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 263d
Cleared May 19, 2017
DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
K162212 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 284d
Cleared May 16, 2017
TRANSLACE™ Spinal Tethering System
K163181 · OWI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 183d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Feb 23, 2017
Medtronic Transportation/Sterilization Cassettes
K163279 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 94d
Cleared Dec 20, 2016
CD HORIZON® Spinal System
K163301 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Dec 14, 2016
SOVEREIGN® Spinal System
K162680 · OVD
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 79d
Cleared Nov 16, 2016
CD HORIZON® Spinal System
K162379 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Oct 04, 2016
CD HORIZON® Spinal System
K162494 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Mar 28, 2016
ANATOMIC PEEK PTC Cervical Fusion System
K160528 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 32d
Cleared Mar 07, 2016
PERIMETER Interbody Fusion Device
K160418 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d