510k
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417
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1261
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311
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958
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181
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1625
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1012
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114
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80
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405
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703
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311
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189
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2288
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43
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379
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1840
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138
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GEX
Powered Laser Surgical Instrument
272
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System, Image Processing,...
256
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Automated Radiological Image...
240
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Electrosurgical, Cutting &...
226
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System, Imaging, Pulsed Doppler,...
226
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Plate, Fixation, Bone
225
OLO
Orthopedic Stereotaxic Instrument
188
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Abutment, Implant, Dental,...
173
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Thoracolumbosacral Pedicle Screw...
155
LZA
Polymer Patient Examination Glove
153
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Trans1, Inc.
Medical Device Manufacturer
·
US , Excelsior , MN
Trans1, Inc. - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2004
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Trans1, Inc.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Apr 01, 2013
TRANS1LATERAL INTERBODY FUSION SYSTEM
K123997
·
MAX
Orthopedic
·
96d
Cleared
Dec 17, 2004
TRANS1 AXIAL FIXATION SYSTEM
K040426
·
KWQ
Orthopedic
·
302d
Cleared
Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891
·
HRX
Orthopedic
·
120d
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3
Orthopedic
3