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"
145–168 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 2013
T2 XVBR SPINAL SYSTEM, T2 ALTITUDE EXPANDABLE CORPECTOMY DEVICE
K131888 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 23, 2013
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K130177 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 241d
Cleared Aug 06, 2013
CD HORIZON SPINAL SYSTEM
K132111 · NKB
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jul 25, 2013
CAPSTONE(R) SPINAL SYSTEM
K123027 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 300d
Cleared Jun 05, 2013
CD HORIZON SPINAL SYSTEM
K131321 · OSH
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jun 04, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 85d
Cleared Apr 19, 2013
MASTERGRAFT STRIP
K130335 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 67d
Cleared Apr 10, 2013
CD HORIZON SPINAL SYSTEM
K130646 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Apr 09, 2013
CAPSTONE L SPINAL SYSTEM
K123978 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 104d
Cleared Apr 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
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 Feb 25, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Jan 31, 2013
MAGNIFUSE BONE GRAFT (CLEARED AS GRAFTON II EDBM)
K123691 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Jan 11, 2013
POWEREASE SYSTEM
K123270 · HBE
Medtronic Sofamor Danek USA, Inc.
Neurology · 84d
Cleared Dec 18, 2012
VERTEX RECONSTRUCTION SYSTEM
K123568 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Nov 16, 2012
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Oct 03, 2012
CD HORIZON SPINAL SYSTEM
K122862 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
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 29, 2012
CAPSTONE SPINAL SYSTEM
K121760 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Aug 21, 2012
CD HORIZON SPINAL SYSTEM
K121764 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 67d
Cleared Jul 26, 2012
SOVEREIGN SPINAL SYSTEM
K121982 · OVD
Medtronic Sofamor Danek
Orthopedic · 20d