510k
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303
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911
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173
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1552
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112
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79
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292
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180
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2202
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42
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362
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1781
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137
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GEX
Powered Laser Surgical Instrument
256
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System, Image Processing,...
239
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232
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System, Imaging, Pulsed Doppler,...
222
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Electrosurgical, Cutting &...
218
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Plate, Fixation, Bone
217
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Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
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Intervertebral Fusion Device...
146
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Senecka Spine
Medical Device Manufacturer
·
US , Johnson City , NY
Senecka Spine - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2015
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Senecka Spine
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 28, 2016
Seneka II Polyscrew Pedicle Fixation System
K153525
·
NKB
Orthopedic
·
50d
Cleared
Sep 30, 2015
Seneka I Polyscrew Pedicle Fixation System
K151849
·
NKB
Orthopedic
·
85d
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Orthopedic
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