FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

174 results for "Medtronic Sofamor Danek USA, Inc."
145–168 of 174
Search insights Median review: 83d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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
Cleared Oct 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d