510k
Database
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Anesthesiology
330
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1055
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268
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793
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148
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619
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1307
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746
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97
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72
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1
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364
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566
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240
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154
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2032
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38
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309
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1570
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130
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
204
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System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
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Thoracolumbosacral Pedicle Screw...
133
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Medtronic Sofamor Danck USA, Inc.
Medical Device Manufacturer
·
US , Memphis , TN
Medtronic Sofamor Danck USA, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 2011
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Medtronic Sofamor Danck USA, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 28, 2015
KYPHON (R) HV-R(R) Bone Cement
K150460
·
NDN
Orthopedic
·
64d
Cleared
Oct 27, 2014
CD HORIZON Spinal System
K142847
·
NKB
Orthopedic
·
27d
Cleared
Nov 15, 2011
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K112444
·
ODP
Orthopedic
·
83d
Cleared
Jun 08, 2011
TSRH SPINAL SYSTEM
K110070
·
NKB
Orthopedic
·
149d
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4
Orthopedic
4