510k
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379
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1188
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288
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163
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1494
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108
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78
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387
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274
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172
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2178
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41
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352
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1732
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136
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GEX
Powered Laser Surgical Instrument
252
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Automated Radiological Image...
229
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System, Image Processing,...
223
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System, Imaging, Pulsed Doppler,...
221
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Plate, Fixation, Bone
216
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Electrosurgical, Cutting &...
208
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Orthopedic Stereotaxic Instrument
180
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
148
MAX
Intervertebral Fusion Device...
146
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Precifit Medical, Ltd.
Medical Device Manufacturer
·
US , Morrisville , NC
Precifit Medical, Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Precifit Medical, Ltd.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 08, 2018
Lumfuse TP
K173189
·
MAX
Orthopedic
·
249d
Cleared
May 04, 2018
Cervage
K172568
·
ODP
Orthopedic
·
252d
Cleared
Jul 25, 2017
LumFuse-TP
K171630
·
MAX
Orthopedic
·
53d
Cleared
May 08, 2017
Precifit Medical Kirschner Wires
K163327
·
HTY
Orthopedic
·
161d
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Orthopedic
4