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398
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300
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905
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172
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1541
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112
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79
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395
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669
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290
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178
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2201
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42
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360
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1776
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137
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GEX
Powered Laser Surgical Instrument
253
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System, Image Processing,...
237
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
221
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Electrosurgical, Cutting &...
218
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Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
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Intervertebral Fusion Device...
146
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K2m, Incorporated
Medical Device Manufacturer
·
US , Leesburg , VA
K2m, Incorporated - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2015
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - K2m, Incorporated
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jul 21, 2016
EVEREST Spinal System
K161369
·
NKB
Orthopedic
·
65d
Cleared
Feb 16, 2016
Caspian OCT/MESA Mini/DENALI Mini Spinal System
K153370
·
NKG
Orthopedic
·
85d
Cleared
Nov 17, 2015
RANGE/DENALI/MESA Spinal System
K153031
·
NKB
Orthopedic
·
29d
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Orthopedic
3