510k
Database
Specialties
Anesthesiology
117
Cardiovascular
507
Chemistry
156
Dental
276
Ear, Nose, Throat
59
Gastroenterology & Urology
258
General & Plastic Surgery
439
General Hospital
339
Hematology
63
Immunology
55
Medical Genetics
0
Microbiology
221
Neurology
133
Obstetrics & Gynecology
43
Ophthalmic
41
Orthopedic
1214
Pathology
18
Physical Medicine
58
Radiology
789
Toxicology
86
Categories
IYN
System, Imaging, Pulsed Doppler,...
145
HRS
Plate, Fixation, Bone
123
OLO
Orthopedic Stereotaxic Instrument
108
LLZ
System, Image Processing,...
93
MAX
Intervertebral Fusion Device...
80
NHA
Abutment, Implant, Dental,...
80
NKB
Thoracolumbosacral Pedicle Screw...
77
MBI
Fastener, Fixation,...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Osteonic Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
Osteonic Co., Ltd. - FDA 510(k) Cleared Devices
20 submissions
·
20 cleared
·
Since 2015
Official Website
20
Total
20
Cleared
0
Denied
FDA 510(k) cleared devices by Osteonic Co., Ltd.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 15, 2021
Ortho MI System
K211992
·
OAT
Dental
·
109d
Cleared
Oct 20, 2016
OPTIMUS CMF SYSTEM
K160363
·
JEY
Dental
·
254d
Cleared
Jan 20, 2015
OPTIMUS CMF SYSTEM
K140037
·
JEY
Dental
·
378d
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Orthopedic
13
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4
Dental
3