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

99 results for "Medtronic Sofamor Danek, Inc."
49–72 of 99
Search insights Median review: 52d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek, Inc. Lead specialty: Orthopedic
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K032578 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Sep 17, 2003
TSRH SPINAL SYSTEM
K031967 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared May 16, 2003
CD HORIZON SPINAL SYSTEM
K030932 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 52d
Cleared May 15, 2003
MODIFICATION TO HORIZON SPINAL SYSTEM
K030840 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 59d
Cleared Apr 22, 2003
MASTERGRAFT MATRIX
K023553 · MQV
Medtronic Sofamor Danek, Inc.
Orthopedic · 181d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 25, 2003
MODIFICATION TO TSRH SPINAL SYSTEM
K030285 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Aug 28, 2002
MODIFICATION TO TENOR SPINAL SYSTEM
K022191 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 54d
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
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 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 03, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K021106 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 26, 2002
MSD WIRE SYSTEM
K020426 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 18d
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