510k
Database
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Anesthesiology
386
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1201
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294
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892
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165
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708
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1521
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109
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78
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1
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392
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663
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285
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176
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2192
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42
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356
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1749
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137
Categories
GEX
Powered Laser Surgical Instrument
253
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Automated Radiological Image...
231
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System, Image Processing,...
227
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System, Imaging, Pulsed Doppler,...
221
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Plate, Fixation, Bone
217
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Electrosurgical, Cutting &...
211
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
149
MAX
Intervertebral Fusion Device...
146
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Sign Fracture Care International
Medical Device Manufacturer
·
US , Richland , WA
Sign Fracture Care International - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2013
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Sign Fracture Care International
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jul 20, 2017
SIGN IM Nail
K163589
·
HSB
Orthopedic
·
212d
Cleared
Feb 25, 2016
SIGN Compression Screw System
K153759
·
HWC
Orthopedic
·
57d
Cleared
Nov 13, 2015
SIGN Hip Construct (SHC)
K152757
·
HSB
Orthopedic
·
50d
Cleared
Apr 16, 2013
SIGN PEDIATRIC FIN NAIL
K122823
·
HSB
Orthopedic
·
214d
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Orthopedic
4