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

99 results for "Medtronic Sofamor Danek, Inc."
1–24 of 99
Search insights Median review: 52d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek, Inc. Lead specialty: Orthopedic
Cleared Jun 12, 2025
Grafton™ DBM
K251193 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Jan 17, 2025
Mastergraft Matrix EXT
K243706 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Sep 05, 2014
MASTERGRAFT MATRIX EXT
K141824 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 60d
Cleared Jul 09, 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 141d
Cleared Mar 25, 2014
CD HORIZON SPINAL SYSTEM
K140449 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 11, 2013
CLYDESDALE SPINAL SYSTEM
K132897 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 86d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Sep 26, 2013
PERIMETER INTERBODY FUSION DEVICE
K132700 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Mar 22, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM CORNERSTONE PSR CERVICAL FUSION SYSTEM...
K122037 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 254d
Cleared Mar 06, 2013
CLEARED UNDER GRAFTON II EDBM
K122513 · MBP
Medtronic Sofamor Danek, Inc.
Orthopedic · 201d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Sep 28, 2012
CD HORIZON SPINAL SYSTEM
K122433 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 49d
Cleared Sep 18, 2012
CLYDESDALE SPINAL SYSTEM
K122591 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Aug 21, 2012
CD HORIZON SPINAL SYSTEM
K121764 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 67d
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d
Cleared Oct 26, 2009
TSRH SPINAL SYSTEM
K093058 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d