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"
73–96 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Jul 06, 2017
CRESCENT™ Spinal System
K171031 · MAX
Medtronic Sofamor Danek
Orthopedic · 91d
Cleared Jun 13, 2017
FUSE Spinal System
K171468 · MAX
Medtronic Sofamor Danek
Orthopedic · 26d
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 May 11, 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the...
K170679 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Apr 04, 2017
CD HORIZON™ Fenestrated Screw Set
K170347 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 60d
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 Aug 12, 2016
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the...
K161210 · OUR
Medtronic Sofamor Danek
Orthopedic · 106d
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
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 Jan 19, 2016
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK...
K153373 · ODP
Medtronic Sofamor Danek
Orthopedic · 57d
Cleared Jan 06, 2016
KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set
K152604 · PML
Medtronic Sofamor Danek USA,...
Orthopedic · 117d
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