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"
409–432 of 440
Search insights Median review: 67d Cleared: 100% Top manufacturer: Medtronic Sofamor Danek USA, Inc. Lead specialty: Orthopedic
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 10, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PEEK
K010528 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 229d
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 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
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 Jun 05, 2001
MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER
K010701 · LYC
Medtronic Sofamor Danek USA, Inc.
Dental · 89d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529 · JDI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
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 Nov 02, 2000
SIMPLICITY SPINAL SYSTEM
K002103 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 113d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 51d