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"
289–312 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Oct 21, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052734 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K052609 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Oct 07, 2005
MODIFICATION TO: VERTE-STACK SPINAL SYSTEM
K052261 · MQP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Sep 23, 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · KWP
Medtronic Sofamor Danek
Orthopedic · 22d
Cleared Sep 23, 2005
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · KWP
Medtronic Sofamor Danek
Orthopedic · 24d
Cleared Sep 09, 2005
SATELLITE SPINAL SYSTEM
K051320 · NVR
Medtronic Sofamor Danek
Orthopedic · 112d
Cleared Aug 31, 2005
TSRH SPINAL SYSTEM
K052144 · NKB
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Aug 23, 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · KWP
Medtronic Sofamor Danek
Orthopedic · 13d
Cleared Aug 22, 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K052187 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Aug 16, 2005
TSRH SPINAL SYSTEM
K052054 · NKB
Medtronic Sofamor Danek
Orthopedic · 18d
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 Jun 09, 2005
BASIS VERTEBRAL BODY SPACER
K051105 · MQP
Medtronic Sofamor Danek
Orthopedic · 38d
Cleared Jun 06, 2005
CENTERPIECE PLATE FIXATION SYSTEM
K050082 · NQW
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
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 May 04, 2005
BASIS SPINAL SYSTEM
K050484 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 68d
Cleared Apr 11, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · KWP
Medtronic Sofamor Danek
Orthopedic · 157d
Cleared Mar 24, 2005
CD HORIZON SPINAL SYSTEM
K050439 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Mar 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043488 · NKB
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Feb 23, 2005
QUADRANT RETRACTOR SYSTEM
K043602 · GAD
Medtronic Sofamor Danek
General & Plastic Surgery · 56d
Cleared Feb 18, 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Feb 17, 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 10, 2005
CD HORIZON SPINAL SYSTEM
K050079 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d