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"
217–240 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Sep 21, 2009
T2 SPINAL SYSTEM
K091883 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Sep 02, 2009
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K091974 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Aug 14, 2009
MODIFICATION TO: TSRH SPINAL SYSTEM
K090740 · NKB
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Jul 15, 2009
CD HORIZON SPINAL SYSTEM
K091442 · NKB
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jun 02, 2009
MASTERGRAFT STRIP
K082166 · MQV
Medtronic Sofamor Danek
Orthopedic · 306d
Cleared May 15, 2009
CD HORIZON SPINAL SYSTEM
K090390 · NKB
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Apr 17, 2009
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K090714 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082918 · MQV
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Jan 09, 2009
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K082917 · LYC
Medtronic Sofamor Danek
Dental · 101d
Cleared Dec 29, 2008
CLYDESDALE SPINAL SYSTEM
K083026 · MAX
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Nov 24, 2008
PROGENIX PLUS
K082002 · MQV
Medtronic Sofamor Danek
Orthopedic · 133d
Cleared Nov 21, 2008
TSRH SPINAL SYSTEM
K081080 · NKB
Medtronic Sofamor Danek
Orthopedic · 219d
Cleared Nov 14, 2008
VERTEX RECONSTRUCTION SYSTEM
K083071 · KWP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Nov 10, 2008
PROGENIX
K082463 · NUN
Medtronic Sofamor Danek
Dental · 75d
Cleared Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Oct 10, 2008
CD HORIZON SPINAL SYSTEM
K082236 · NKB
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Sep 17, 2008
MASTERGRAFT PUTTY
K081784 · LYC
Medtronic Sofamor Danek
Dental · 85d
Cleared Sep 12, 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · MAX
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Aug 27, 2008
T2 XVBR SPINAL SYSTEM
K082112 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Aug 15, 2008
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K081038 · KWQ
Medtronic Sofamor Danek
Orthopedic · 126d
Cleared Jul 18, 2008
PROGENIX PLUS
K081950 · NUN
Medtronic Sofamor Danek, Inc.
Dental · 9d
Cleared Jun 16, 2008
AXIS FIXATION SYSTEM
K062254 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 682d
Cleared Jun 11, 2008
VERTEX RECONSTRUCTION SYSTEM
K081297 · KWP
Medtronic Sofamor Danek
Orthopedic · 35d