510k
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410
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1237
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309
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936
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179
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726
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1590
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984
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113
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80
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4
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400
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692
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298
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184
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2242
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43
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371
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1811
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138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
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
HRS
Plate, Fixation, Bone
219
OLO
Orthopedic Stereotaxic Instrument
184
NHA
Abutment, Implant, Dental,...
169
NKB
Thoracolumbosacral Pedicle Screw...
151
MAX
Intervertebral Fusion Device...
149
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Skeletal Kinetics, LLC
Medical Device Manufacturer
·
US , Washington , DC
Skeletal Kinetics, LLC - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 2003
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Skeletal Kinetics, LLC
Neurology
✕
2
devices
1-2 of 2
Filters
Cleared
Jan 13, 2017
OsteoVation Impact
K162864
·
GXP
Neurology
·
92d
Cleared
Sep 16, 2004
CALLOS CMF BONE VOID FILLER
K042072
·
GXP
Neurology
·
45d
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10
Orthopedic
6
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2
General & Plastic Surgery
2