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."
73–96 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Mar 07, 2016
PERIMETER Interbody Fusion Device
K160418 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Mar 02, 2016
PERIMETER C (Titanium) Spinal System
K153438 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 96d
Cleared Feb 18, 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for...
K153442 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 83d
Cleared Feb 10, 2016
CD HORIZON Spinal System
K153589 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 56d
Cleared Jan 20, 2016
Medtronic Transportation/Sterilization Cassettes
K152241 · KCT
Medtronic Sofamor Danek USA, Inc.
General Hospital · 163d
Cleared Dec 30, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K153463 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Nov 13, 2015
PIVOX(tm) Oblique Lateral Spinal System
K152277 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 93d
Cleared Nov 12, 2015
ATLANTIS Anterior Cervical Plate System
K152623 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 59d
Cleared Nov 05, 2015
CD HORIZON Spinal System
K152248 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Oct 28, 2015
VERTEX(r) Reconstruction System
K152338 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 70d
Cleared Oct 27, 2015
CD HORIZON Spinal System
K152457 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 60d
Cleared Aug 14, 2015
MASTERGRAFT Contain
K151172 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 105d
Cleared Aug 06, 2015
CAPSTONE Spinal System, CLYDESDALE Spinal System
K151128 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 100d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Jun 11, 2015
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
K150135 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 141d
Cleared Jun 09, 2015
ELEVATE Spinal System
K142559 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 271d
Cleared May 22, 2015
SPINEDESIGN Spine Surgery Planning (Software Application)
K142648 · LLZ
Medtronic Sofamor Danek USA, Inc.
Radiology · 247d
Cleared Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460 · NDN
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 64d
Cleared Apr 08, 2015
CD HORIZON Spinal System, IPC POWEREASE System
K143019 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 170d
Cleared Feb 13, 2015
CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
K143375 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 80d
Cleared Feb 12, 2015
Navigated Vertex Select Instruments
K143628 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d
Cleared Feb 12, 2015
CD HORIZON Spinal System
K143569 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 58d
Cleared Feb 11, 2015
CD HORIZON SPINAL SYSTEM
K150178 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Feb 06, 2015
VERTEX Reconstruction System
K143471 · NKG
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d