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"
169–192 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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
Cleared May 30, 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · JEY
Medtronic Sofamor Danek USA, Inc.
Dental · 121d
Cleared May 29, 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · OUR
Medtronic Sofamor Danek
Orthopedic · 466d
Cleared Apr 09, 2012
CAPSTONE CONTROL SPINAL SYSTEM
K120368 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Feb 09, 2012
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB
Medtronic Sofamor Danek
Orthopedic · 71d
Cleared Feb 06, 2012
PERIMETER INTERBODY FUSION DEVICE
K113642 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 56d
Cleared Jan 17, 2012
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · OVE
Medtronic Sofamor Danek
Orthopedic · 75d
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 Nov 09, 2011
TELAMON PEEK SPINAL SYSTEM
K110562 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 254d
Cleared Oct 21, 2011
CD HORIZON SPINAL SYSTEM
K112473 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 56d
Cleared Oct 12, 2011
CORNERSTONE (R) PSR CERVICAL FUSION SYSTEM
K111264 · ODP
Medtronic Sofamor Danek USA
Orthopedic · 161d
Cleared Oct 04, 2011
SOVEREIGN SPINAL SYSTEM
K110063 · OVD
Medtronic Sofamor Danek, Inc.
Orthopedic · 267d
Cleared Sep 27, 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111510 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 106d
Cleared Sep 15, 2011
CD HORIZON SPINAL SYSTEM
K111457 · NKB
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Aug 30, 2011
TSRH SPINAL SYSTEMS
K111942 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 53d
Cleared Aug 24, 2011
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX
Medtronic Sofamor Danek
Orthopedic · 84d
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 Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · MAX
Medtronic Sofamor Danek
Orthopedic · 208d
Cleared May 23, 2011
TSRH SPINAL SYSTEM
K110676 · NKB
Medtronic Sofamor Danek
Orthopedic · 74d