510k
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731
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187
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459
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88
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761
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77
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62
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274
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76
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1468
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26
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151
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1079
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93
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IYN
System, Imaging, Pulsed Doppler,...
165
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Plate, Fixation, Bone
150
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Orthopedic Stereotaxic Instrument
129
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Powered Laser Surgical Instrument
123
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System, Image Processing,...
123
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Automated Radiological Image...
109
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Abutment, Implant, Dental,...
104
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Electrosurgical, Cutting &...
104
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Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Biofusion Medical
Medical Device Manufacturer
·
US , Austin , TX
Biofusion Medical - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Biofusion Medical
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 17, 2020
SI-Restore Sacroiliac Joint Fixation System
K200868
·
OUR
Orthopedic
·
16d
Cleared
Jan 25, 2019
SI-Restore® Sacroiliac Joint Fixation System
K182919
·
OUR
Orthopedic
·
98d
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Orthopedic
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