Medical Device Manufacturer · US , Memphis , TN

Medtronic Sofamor Danek, Inc. - FDA 510(k) Cleared Devices

99 submissions · 89 cleared · Since 2000
99
Total
89
Cleared
0
Denied
98 devices
76-98 of 98
Cleared Oct 04, 2001
BLOCK CEMENT RESTRICTOR (CR) - TITANIUM
K013014 · JDK
Orthopedic · 27d
Cleared Oct 01, 2001
DYNAMIC COMPRESSION SHAPE MEMORY ALLOY (SMA) STAPLE SYSTEM
K012081 · JDR
Orthopedic · 90d
Cleared Sep 28, 2001
VERTEX RECONSTRUCTION SYSTEM
K003780 · KWP
Orthopedic · 295d
Cleared Aug 01, 2001
MEDTRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K012255 · JDK
Orthopedic · 14d
Cleared Jul 26, 2001
METRONIC SOFAMOR DANEK CEMENT RESTRICTOR
K011998 · JDK
Orthopedic · 29d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM, 4.5 ROD FOR POSTERIOR APPLICATION
K010181 · KWP
Orthopedic · 144d
Cleared Jun 12, 2001
CD HORIZON SPINAL SYSTEM
K011508 · KWP
Orthopedic · 27d
Cleared Jun 05, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011029 · MNI
Orthopedic · 61d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Orthopedic · 25d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · MNH
Orthopedic · 30d
Cleared Feb 23, 2001
CD HORIZON SPINAL SYSTEM
K010249 · MNH
Orthopedic · 28d
Cleared Feb 14, 2001
TITANIUM CEMENT RESTRICTOR (TCR)
K003718 · JDK
Orthopedic · 72d
Cleared Jan 17, 2001
TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
K003928 · MRW
Orthopedic · 28d
Cleared Dec 22, 2000
CD HORIZON SPINAL SYSTEM
K000641 · MNH
Orthopedic · 301d
Cleared Nov 24, 2000
METRX SYSTEM
K002931 · HRX
Orthopedic · 65d
Cleared Sep 27, 2000
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K002399 · MNH
Orthopedic · 51d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Orthopedic · 83d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Orthopedic · 80d
Cleared Jun 19, 2000
ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
K994239 · KWQ
Orthopedic · 186d
Cleared Jun 16, 2000
DYNA-LOK CLASSIC SPINAL SYSTEM
K001532 · KWP
Orthopedic · 30d
Cleared Apr 18, 2000
MODIFICATION TO TSRH SPINAL SYSTEM
K000991 · MNI
Orthopedic · 21d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · MNH
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · MNH
Orthopedic · 25d

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