510k
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392
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298
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901
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169
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1537
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111
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79
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286
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177
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2199
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42
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360
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1765
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137
Categories
GEX
Powered Laser Surgical Instrument
253
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System, Image Processing,...
232
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Automated Radiological Image...
232
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System, Imaging, Pulsed Doppler,...
221
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Electrosurgical, Cutting &...
218
HRS
Plate, Fixation, Bone
217
OLO
Orthopedic Stereotaxic Instrument
182
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Abutment, Implant, Dental,...
169
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Thoracolumbosacral Pedicle Screw...
150
MAX
Intervertebral Fusion Device...
146
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Eden Spine, LLC
Medical Device Manufacturer
·
US , Apple Valley , MN
Eden Spine, LLC - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2012
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eden Spine, LLC
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 22, 2016
Sphynx™
K160982
·
KWQ
Orthopedic
·
259d
Cleared
Jan 26, 2012
GIZA(R) VERTEBRAL BODY REPLACEMENT
K112429
·
MQP
Orthopedic
·
156d
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Orthopedic
2