510k
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144
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584
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167
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328
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68
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297
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543
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387
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67
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58
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236
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175
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70
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53
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1308
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19
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91
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891
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88
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IYN
System, Imaging, Pulsed Doppler,...
152
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Plate, Fixation, Bone
138
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Orthopedic Stereotaxic Instrument
118
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System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
84
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
JAK
System, X-ray, Tomography, Computed
79
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Bright Spine
Medical Device Manufacturer
·
US , Boca Raton , FL
Bright Spine - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2020
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Bright Spine
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 13, 2023
Galileo Vertebral Body Replacement Device
K221542
·
PLR
Orthopedic
·
231d
Cleared
Apr 21, 2020
Galileo Vertebral Body Replacement Device
K192145
·
PLR
Orthopedic
·
257d
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Orthopedic
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