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."
73–96 of 99
Search insights Median review: 52d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek, Inc. Lead specialty: Orthopedic
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
Cleared Dec 05, 2001
CEMENT RESTRICTOR
K013663 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Oct 24, 2001
LIFT VB SPINAL SYSTEM
K010930 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 210d
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Medtronic Sofamor Danek, Inc.
Orthopedic · 90d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 295d
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 14d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 144d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 61d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · JDK
Medtronic Sofamor Danek, Inc.
Orthopedic · 72d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 301d
Cleared Nov 24, 2000
METRX SYSTEM
K002931 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 65d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d
Cleared Jun 19, 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 186d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d