510k
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1306
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327
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1004
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190
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781
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1697
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1101
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117
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83
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412
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732
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321
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199
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2365
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44
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393
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1898
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140
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GEX
Powered Laser Surgical Instrument
281
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System, Image Processing,...
267
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Automated Radiological Image...
246
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Electrosurgical, Cutting &...
239
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System, Imaging, Pulsed Doppler,...
232
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Plate, Fixation, Bone
231
OLO
Orthopedic Stereotaxic Instrument
194
NHA
Abutment, Implant, Dental,...
180
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Polymer Patient Examination Glove
170
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Thoracolumbosacral Pedicle Screw...
161
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X-Sten Corp.
Medical Device Manufacturer
·
US , San Jose , CA
X-Sten Corp. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2006
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - X-Sten Corp.
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Feb 04, 2010
VERTOS MEDICAL MILD DEVICE KIT
K093062
·
HRX
Orthopedic
·
127d
Cleared
Dec 19, 2006
X-STEN MILD TOOL KIT, MODEL MTK-0001
K062038
·
HRX
Orthopedic
·
153d
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Orthopedic
2