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"
241–264 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared May 15, 2008
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 174d
Cleared May 13, 2008
PROGENIX DBM PUTTY
K080462 · NUN
Medtronic Sofamor Danek
Dental · 83d
Cleared Apr 30, 2008
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM
K080429 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Apr 24, 2008
CAPSTONE SPINAL SYSTEM
K073291 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 153d
Cleared Apr 18, 2008
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K080805 · KWP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Apr 10, 2008
INTREPID SPINAL SYSTEM
K080083 · MAX
Medtronic Sofamor Danek
Orthopedic · 90d
Cleared Jan 09, 2008
PROGENIX DMB PUTTY
K072265 · MQV
Medtronic Sofamor Danek
Orthopedic · 147d
Cleared Dec 11, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K071942 · KWP
Medtronic Sofamor Danek
Orthopedic · 151d
Cleared Nov 09, 2007
MASTERGRAFT PUTTY
K071813 · MQV
Medtronic Sofamor Danek
Orthopedic · 130d
Cleared Nov 01, 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Oct 15, 2007
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062447 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 419d
Cleared Sep 28, 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · NKB
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Sep 18, 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Sep 14, 2007
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K070742 · KWP
Medtronic Sofamor Danek
Orthopedic · 182d
Cleared Aug 14, 2007
T2 XVBR SPINAL SYSTEM
K071033 · MQP
Medtronic Sofamor Danek
Orthopedic · 124d
Cleared Jun 28, 2007
MODIFICATIONS TO CD HORIZON SPINAL SYSTEM
K063670 · NKB
Medtronic Sofamor Danek
Orthopedic · 199d
Cleared May 04, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K070527 · NDN
Medtronic Sofamor Danek
Orthopedic · 70d
Cleared Mar 14, 2007
VERTE-STACK SPINAL SYSTEM
K070173 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 55d
Cleared Mar 13, 2007
ARCUATE VERTEBRAL AUGMENTATION SYSTEM
K063248 · NDN
Medtronic Sofamor Danek
Orthopedic · 138d
Cleared Mar 05, 2007
T2 SCEPTOR SPINAL SYSTEM
K063491 · MQP
Medtronic Sofamor Danek
Orthopedic · 108d
Cleared Feb 23, 2007
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM, TRANSLATIONAL PLATE
K063100 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 136d
Cleared Jan 18, 2007
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K063417 · NKB
Medtronic Sofamor Danek
Orthopedic · 66d
Cleared Jan 05, 2007
MODIFICATION TO: SATELLITE SPINAL SYSTEM
K060415 · NVR
Medtronic Sofamor Danek
Orthopedic · 322d
Cleared Dec 22, 2006
TRAVERSE OCT SPINAL FIXATION SYSTEM
K062879 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 87d