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."
25–48 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Dec 08, 2021
Anteralign Spinal System with Titan nanoLOCK Surface Technology
K212524 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 119d
Cleared Nov 19, 2021
Catalyft LS Expandable Interbody System
K212653 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jul 21, 2021
CD Horizon Spinal System
K211958 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 27d
Cleared Jun 09, 2021
Navigated Anterolateral Disc Prep Instruments
K211441 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 26, 2021
Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System,...
K211258 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 24, 2021
Catalyft PL Expandable Interbody System
K210425 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 102d
Cleared Jan 15, 2021
CD HORIZON™ Spinal System
K203678 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 10, 2020
CD Horizon™ Spinal System
K201407 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Sep 08, 2020
CD Horizon Spinal System
K202328 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 22d
Cleared Mar 23, 2020
CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal...
K191788 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 264d
Cleared Jan 22, 2020
Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion...
K192502 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 132d
Cleared Jan 10, 2020
CD Horizon™ Fenestrated Screw Set
K193011 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 86d
Cleared Oct 15, 2019
Medtronic Transportation / Sterilization Cassettes
K190840 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 197d
Cleared Oct 03, 2019
CD Horizon™ Astute™ Spinal System
K191066 · NQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
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