510k
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411
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1242
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309
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940
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180
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728
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1593
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988
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113
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80
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298
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184
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2246
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43
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371
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1813
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138
Categories
GEX
Powered Laser Surgical Instrument
261
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System, Image Processing,...
255
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Automated Radiological Image...
236
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System, Imaging, Pulsed Doppler,...
224
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Electrosurgical, Cutting &...
222
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Plate, Fixation, Bone
220
OLO
Orthopedic Stereotaxic Instrument
184
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
152
MAX
Intervertebral Fusion Device...
149
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New Era Orthopaedics, LLC
Medical Device Manufacturer
·
US , Round Rock , TX
New Era Orthopaedics, LLC - FDA 510(k) Cleared Devices
1 submissions
·
1 cleared
·
Since 2015
1
Total
1
Cleared
0
Denied
FDA 510(k) Regulatory Record - New Era Orthopaedics, LLC
Orthopedic
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 09, 2015
NEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEM
K141253
·
MNI
Orthopedic
·
240d
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Orthopedic
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