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

175 results for "Medtronic Sofamor Danek USA, Inc."
121–144 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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 01, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM
K123906 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 103d
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 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 Oct 03, 2012
CD HORIZON SPINAL SYSTEM
K122862 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 16d
Cleared Aug 29, 2012
CAPSTONE SPINAL SYSTEM
K121760 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared Jul 05, 2012
CD HORIZON SPINAL SYSTEM
K121680 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 30, 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 121d
Cleared Apr 09, 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Dec 20, 2011
CLYDESDALE(R) SPINAL SYSTEM
K113528 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared Nov 21, 2011
CD HORIZON SPINAL SYSTEM
K113174 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 91d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d
Cleared Aug 09, 2011
CRESCENT (R) SPINAL SYSTEM TITANIUM
K110543 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 165d
Cleared Aug 05, 2011
PERIMETER C SPINAL SYSTEM
K100967 · ODP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 484d
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 Dec 13, 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 269d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d