510k
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Anesthesiology
204
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739
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187
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467
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91
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394
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776
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476
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77
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64
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1
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277
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302
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117
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79
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1477
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26
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153
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1094
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94
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IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
131
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Powered Laser Surgical Instrument
126
LLZ
System, Image Processing,...
125
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Automated Radiological Image...
112
GEI
Electrosurgical, Cutting &...
105
NHA
Abutment, Implant, Dental,...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Spineway SA
Medical Device Manufacturer
·
FR , Ecully
Spineway SA - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2016
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Spineway SA
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Sep 12, 2019
mont blanc & mont blanc MIS Spinal Systems
K191726
·
NKB
Orthopedic
·
77d
Cleared
Aug 04, 2016
Mont Blanc and Mont Blanc MIS Spinal Systems
K161387
·
NKB
Orthopedic
·
77d
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Orthopedic
2