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

99 results for "Medtronic Sofamor Danek, Inc."
25–48 of 99
Search insights Median review: 52d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek, Inc. Lead specialty: Orthopedic
Cleared Oct 02, 2009
TSRH SPINAL SYSTEM
K092676 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 31d
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 Oct 15, 2007
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 419d
Cleared Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
K070173 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 55d
Cleared Feb 23, 2007
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
K063100 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 136d
Cleared Dec 22, 2006
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 87d
Cleared Nov 06, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063083 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Nov 06, 2006
TSRH SPINAL SYSTEM
K062807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 48d
Cleared Sep 08, 2006
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K061591 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 92d
Cleared Aug 09, 2006
VERTE-STACK SPINAL SYSTEM
K061938 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Jul 03, 2006
MODIFICATION TO CD HORIZON SYSTEM
K061592 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Jun 06, 2005
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · NQW
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared May 04, 2005
BASIS SPINAL SYSTEM
K050484 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared Mar 24, 2005
CD HORIZON SPINAL SYSTEM
K050439 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 19, 2004
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 23, 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 149d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 28, 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 12, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 03, 2003
MODIFICATION TO EQUATION FIXATION SYSTEM
K033495 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d