Medical Device Manufacturer · US , Memphis , TN

Medtronic Sofamor Danek

154 submissions · 147 cleared · Since 2002
154
Total
147
Cleared
0
Denied

Medtronic Sofamor Danek — FDA 510(k) Submissions

Medtronic Sofamor Danek has submitted 154 FDA 510(k) premarket notifications since 2002, of which 147 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Thoracolumbosacral Pedicle Screw System, Appliance, Fixation, Spinal Interlaminal, Spinal Vertebral Body Replacement Device, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Bone Graft, Lumbar . Use the specialty filter in the sidebar to narrow results.

154 devices
1–25 of 154
Centerpiece Plate Fixation System
K212428 · NQW Orthosis, Spine, Plate,... · Orthopedic
Dec 2021 131d
Adaptix Interbody System with Titan nanoLOCK Surface Technology
K201267 · MAX Intervertebral Fusion... · Orthopedic
Aug 2020 106d
T2 STRATOSPHERE? Expandable Corpectomy System
K173125 · MQP Spinal Vertebral Body... · Orthopedic
Dec 2017 82d
ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium
K172199 · MAX Intervertebral Fusion... · Orthopedic
Sep 2017 60d
CRESCENT? Spinal System
K171031 · MAX Intervertebral Fusion... · Orthopedic
Jul 2017 91d
FUSE Spinal System
K171468 · MAX Intervertebral Fusion... · Orthopedic
Jun 2017 26d
CD HORIZON? Spinal System, Medtronic Reusable Instruments for Use with the IPC? POWEREASE? System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION? and IPC? POWEREASE? Systems
K170679 · NKB Thoracolumbosacral... · Orthopedic
May 2017 66d
RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems
K161210 · OUR Sacroiliac Joint Fixation · Orthopedic
Aug 2016 106d
CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device
K153373 · ODP Intervertebral Fusion... · Orthopedic
Jan 2016 57d
CD HORIZON SPINAL SYSTEM
K140276 · OSH Pedicle Screw Spinal... · Orthopedic
Mar 2014 38d
CD HORIZON SPIRE Z SPINAL SYSTEM
K123246 · NKB Thoracolumbosacral... · Orthopedic
Nov 2012 30d
SOVEREIGN SPINAL SYSTEM
K121982 · OVD Intervertebral Fusion... · Orthopedic
Jul 2012 20d
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · OUR Sacroiliac Joint Fixation · Orthopedic
May 2012 466d
CD HORIZON VOYAGER SPINAL SYSTEM
K113529 · NKB Thoracolumbosacral... · Orthopedic
Feb 2012 71d
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K113252 · OVE Intervertebral Fusion... · Orthopedic
Jan 2012 75d
CD HORIZON SPINAL SYSTEM
K111457 · NKB Thoracolumbosacral... · Orthopedic
Sep 2011 112d
PERIMETER INTERBODY FUSION DEVICE
K111525 · MAX Intervertebral Fusion... · Orthopedic
Aug 2011 84d
CAPSTONE R SPINAL SYSTEM
K103731 · MAX Intervertebral Fusion... · Orthopedic
Jul 2011 208d
TSRH SPINAL SYSTEM
K110676 · NKB Thoracolumbosacral... · Orthopedic
May 2011 74d
TSRH SPINAL SYSTEM
K103049 · NKB Thoracolumbosacral... · Orthopedic
Dec 2010 69d
TSRH(R) SPINAL SYSTEM
K101772 · NKB Thoracolumbosacral... · Orthopedic
Sep 2010 98d
CD HORIZON SPINAL SYSTEM
K091445 · NKB Thoracolumbosacral... · Orthopedic
Sep 2010 500d
LEGEND POWER ADAPTER MODEL: 6475000
K101168 · HBB Motor, Drill, Pneumatic · Neurology
Aug 2010 120d
PEEK PREVAIL CERVICAL INTERBODY DEVICE
K094042 · OVE Intervertebral Fusion... · Orthopedic
Jun 2010 182d
CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE
K100214 · ODP Intervertebral Fusion... · Orthopedic
Jun 2010 151d

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