510k
Database
Specialties
Anesthesiology
410
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1237
Chemistry
309
Dental
936
Ear, Nose, Throat
179
Gastroenterology & Urology
726
General & Plastic Surgery
1590
General Hospital
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
Toxicology
138
Categories
GEX
Powered Laser Surgical Instrument
261
LLZ
System, Image Processing,...
255
QIH
Automated Radiological Image...
236
IYN
System, Imaging, Pulsed Doppler,...
224
GEI
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
General & Plastic Surgery
✕
2
devices
1-2 of 2
Filters
Cleared
Oct 25, 2011
SKAFFOLD CIS
K111538
·
MTJ
General & Plastic Surgery
·
145d
Cleared
Jul 20, 2005
OSTEOVATION CMF BONE VOID FILLER
K051784
·
GXP
General & Plastic Surgery
·
19d
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10
Orthopedic
6
Neurology
2
General & Plastic Surgery
2