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"
361–384 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · MNI
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · MNI
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Aug 11, 2003
CD HORIZON SPINAL SYSTEM
K032265 · KWQ
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
K031780 · MQP
Medtronic Sofamor Danek
Orthopedic · 50d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
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 Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
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 Apr 18, 2003
MODIFIED VERTE-STACK SPINAL SYSTEM
K030735 · MQP
Medtronic Sofamor Danek
Orthopedic · 39d
Cleared Apr 02, 2003
VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES
K030736 · MQP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Mar 25, 2003
VERTE-STACK SPINAL SYSTEM
K030601 · MQP
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Feb 26, 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · KWQ
Medtronic Sofamor Danek
Orthopedic · 26d
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 Dec 13, 2002
LAURAIN DEWALD ANTERIOR FIXATION SYSTEM
K023797 · KWP
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Dec 13, 2002
MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM
K023415 · KWP
Medtronic Sofamor Danek
Orthopedic · 63d
Cleared Dec 10, 2002
CD HORIZON SPINAL SYSTEM
K014296 · KWP
Medtronic Sofamor Danek
Orthopedic · 344d
Cleared Nov 22, 2002
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K023555 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Nov 19, 2002
MODIFICATION TO VERTE-STACK SPINAL SYSTEM
K023570 · MQP
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Sep 18, 2002
MODIFICATION TO TSRH SPINAL SYSTEM
K022778 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d