510k
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1683
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370
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1341
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250
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978
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2199
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126
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99
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967
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436
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279
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2952
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52
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515
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2455
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155
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LZA
Polymer Patient Examination Glove
409
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System, Image Processing,...
391
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358
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Powered Laser Surgical Instrument
356
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Electrosurgical, Cutting &...
307
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System, Imaging, Pulsed Doppler,...
299
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Plate, Fixation, Bone
281
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Automated Radiological Image...
276
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Orthopedic Stereotaxic Instrument
228
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Intervertebral Fusion Device...
220
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Fusion Robotics, LLC
Medical Device Manufacturer
·
US , Louisville , CO
Fusion Robotics, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2022
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Fusion Robotics, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Mar 13, 2023
Remi Robotic Navigation System
K223350
·
OLO
Orthopedic
·
131d
Cleared
Oct 28, 2022
Remi Robotic Navigation System
K223070
·
OLO
Orthopedic
·
28d
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Orthopedic
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