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"
385–408 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Sep 17, 2002
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K021761 · KWQ
Medtronic Sofamor Danek
Orthopedic · 111d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
Cleared Aug 26, 2002
VERTE-STACK SPINAL SYSTEM
K021791 · MQP
Medtronic Sofamor Danek
Orthopedic · 87d
Cleared Jul 25, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K021061 · KWP
Medtronic Sofamor Danek
Orthopedic · 114d
Cleared Jul 24, 2002
MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM
K021705 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 62d
Cleared Jul 22, 2002
XANTUS ANTERIOR LATERAL SUPPLEMENTAL FIXATION SYSTEM
K022070 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 26d
Cleared Jul 22, 2002
ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
K021461 · KWQ
Medtronic Sofamor Danek
Orthopedic · 76d
Cleared Jul 22, 2002
MASTERGRAFT RESORBABLE CERAMIC
K020986 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 117d
Cleared Jul 22, 2002
COLORADO 2 SPINAL SYSTEM
K020247 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 179d
Cleared Jul 18, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K022015 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jul 09, 2002
TSRH SPINAL SYSTEM
K021170 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Jun 20, 2002
EQUATION FIXATION SYSTEM
K013962 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 199d
Cleared May 28, 2002
TSRH SPINAL SYSTEM
K020699 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 88d
Cleared May 13, 2002
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K021226 · KWQ
Medtronic Sofamor Danek
Orthopedic · 25d
Cleared May 09, 2002
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K020709 · KWP
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared May 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Mar 07, 2002
MASTERGRAFT RESORBABLE CERAMIC GRANULES
K012506 · MQV
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 213d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
Cleared Feb 05, 2002
DYNA-LOK CLASSIC SPINAL SYSTEM
K020155 · KWP
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jan 29, 2002
PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K013665 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 84d
Cleared Jan 25, 2002
BUTTERFLY PLATE FIXATION SYSTEM
K014267 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Dec 27, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K014076 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 16d
Cleared Dec 27, 2001
SPINAL MESH SYSTEM
K011406 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 233d
Cleared Dec 19, 2001
MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K013829 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d