510k
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308
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929
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179
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1584
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113
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79
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400
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689
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296
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183
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2235
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43
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370
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1809
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138
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260
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System, Image Processing,...
255
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236
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224
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Electrosurgical, Cutting &...
221
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Plate, Fixation, Bone
218
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Orthopedic Stereotaxic Instrument
183
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
151
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Intervertebral Fusion Device...
148
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Ebi, LLC
Medical Device Manufacturer
·
US , Parsippany , NJ
Ebi, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2011
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Ebi, LLC
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Dec 15, 2014
NEXTGEN ALTIUS OCT SYSTEM
K140734
·
KWP
Orthopedic
·
266d
Cleared
Apr 24, 2014
POLARIS SPINAL SYSTEM -TRANSLATION SCREW
K140123
·
NKB
Orthopedic
·
98d
Cleared
Apr 26, 2012
SOLITAIRE-C CERVICAL SPACER SYSTEM
K113796
·
OVE
Orthopedic
·
125d
Cleared
Aug 03, 2011
CONSTRUX EXTERNAL FIXATION DEVICE
K111376
·
KTT
Orthopedic
·
79d
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Orthopedic
4