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164
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108
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2187
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41
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355
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1744
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137
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GEX
Powered Laser Surgical Instrument
252
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Automated Radiological Image...
230
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226
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System, Imaging, Pulsed Doppler,...
221
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Plate, Fixation, Bone
217
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Electrosurgical, Cutting &...
211
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Orthopedic Stereotaxic Instrument
181
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Intrafuse, LLC
Medical Device Manufacturer
·
US , Logan , UT
Intrafuse, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2017
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intrafuse, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 30, 2017
Flex-Thread Fibula Pin System
K172943
·
HSB
Orthopedic
·
34d
Cleared
Mar 20, 2017
Flex-Thread Clavicle Pin System
K163488
·
HSB
Orthopedic
·
98d
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Orthopedic
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