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.
Neurology
✕
4
devices
1-4 of 4
Filters
Cleared
Jan 27, 2022
Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models),...
K210360
·
GWO
Neurology
·
353d
Cleared
Nov 27, 2019
Optimus NEURO System - Sterile Kit
K190811
·
GWO
Neurology
·
243d
Cleared
Jan 02, 2019
Optimus Neuro System
K183352
·
GWO
Neurology
·
30d
Cleared
Feb 10, 2015
OPTIMUS NEURO SYSTEM
K141911
·
GWO
Neurology
·
210d
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Orthopedic
13
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4
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3