510k
Database
Specialties
Anesthesiology
401
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1214
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303
Dental
911
Ear, Nose, Throat
173
Gastroenterology & Urology
717
General & Plastic Surgery
1552
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938
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112
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79
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3
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395
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673
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292
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180
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2202
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42
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362
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1781
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137
Categories
GEX
Powered Laser Surgical Instrument
256
LLZ
System, Image Processing,...
239
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Automated Radiological Image...
232
IYN
System, Imaging, Pulsed Doppler,...
222
GEI
Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Dne, LLC
Medical Device Manufacturer
·
US , Round Rock , TX
Dne, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dne, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Feb 16, 2016
D.N.E. External Fixation System
K151580
·
KTT
Orthopedic
·
250d
Cleared
May 29, 2014
S.E.A.L. FRACTURE FUSION TUBE
K140158
·
KTT
Orthopedic
·
127d
Cleared
Jan 04, 2012
DNE EXTERNAL FIXATION SYSTEM
K113106
·
KTT
Orthopedic
·
76d
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3
Orthopedic
3