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."
145–168 of 175
Search insights Median review: 84d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Oct 21, 2010
T2 XVBR 1.5 SPINAL SYSTEM
K100976 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 196d
Cleared Jun 22, 2010
MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM
K101074 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 64d
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 Sep 21, 2009
T2 SPINAL SYSTEM
K091883 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Sep 02, 2009
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K091974 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Jan 16, 2009
VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K082728 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 120d
Cleared Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 15, 2008
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K073285 · OVE
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 174d
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 Nov 01, 2007
PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM
K071416 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 164d
Cleared Sep 18, 2007
MODIFICATION TO:TSRH SPINAL SYSTEM
K072317 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 08, 2006
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · FMF
Medtronic Sofamor Danek USA, Inc.
General Hospital · 70d
Cleared Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Jul 21, 2005
CD HORIZON SPINAL SYSTEM
K051674 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jun 14, 2005
CD HORIZON SPINAL SYSTEM
K050809 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 75d
Cleared May 17, 2005
CD HORIZON SPINAL SYSTEM
K050981 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared May 12, 2005
BASIS SPINAL SYSTEM
K051039 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 17d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 01, 2004
CD HORIZON SPINAL SYSTEM
K041460 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d