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"
193–216 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Apr 13, 2011
ARCHITEX SPACE MAINTENANCE SYSTEM
K110259 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 75d
Cleared Apr 01, 2011
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K110522 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 37d
Cleared Jan 26, 2011
CD HORIZON SPINAL SYSTEM
K102886 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 118d
Cleared Dec 23, 2010
TSRH SPINAL SYSTEM
K103049 · NKB
Medtronic Sofamor Danek
Orthopedic · 69d
Cleared Dec 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 269d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Sep 30, 2010
TSRH(R) SPINAL SYSTEM
K101772 · NKB
Medtronic Sofamor Danek
Orthopedic · 98d
Cleared Sep 27, 2010
CD HORIZON SPINAL SYSTEM
K091445 · NKB
Medtronic Sofamor Danek
Orthopedic · 500d
Cleared Aug 24, 2010
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · HBB
Medtronic Sofamor Danek
Neurology · 120d
Cleared Jun 30, 2010
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · OVE
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Jun 25, 2010
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · ODP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
Cleared Jun 02, 2010
CLYDESDALE SPINAL SYSTEM
K100175 · MAX
Medtronic Sofamor Danek
Orthopedic · 132d
Cleared Apr 30, 2010
TSRH SPINAL SYSTEM
K091797 · NKB
Medtronic Sofamor Danek
Orthopedic · 317d
Cleared Apr 26, 2010
CRESCENT SPINAL SYSTEM
K094025 · MAX
Medtronic Sofamor Danek
Orthopedic · 117d
Cleared Dec 30, 2009
MEDTRONIC DENTAL TCP
K092087 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 174d
Cleared Dec 15, 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 02, 2009
VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM
K093434 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Nov 17, 2009
INTREPID SPINAL SYSTEM
K091813 · OVD
Medtronic Sofamor Danek
Orthopedic · 152d
Cleared Oct 26, 2009
TSRH SPINAL SYSTEM
K093058 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Oct 02, 2009
TSRH SPINAL SYSTEM
K092676 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 31d
Cleared Sep 29, 2009
PERIMETER INTERBODY FUSION DEVICE
K090353 · MAX
Medtronic Sofamor Danek
Orthopedic · 230d