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

175 results for "Medtronic Sofamor Danek USA, Inc."
49–72 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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 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