FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

438 results for "Medtronic Sofamor Danek"
145–168 of 438
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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
Cleared Jul 05, 2012
CD HORIZON SPINAL SYSTEM
K121680 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jun 29, 2012
VERTEX RCCONSTRUCTION SYSTEM
K121191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 71d