510k
Database
Specialties
Anesthesiology
140
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576
Chemistry
167
Dental
323
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
533
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
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173
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66
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51
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1299
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18
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88
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882
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
135
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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CG Bio Co., Ltd.
Medical Device Manufacturer
·
KR , Seoul
CG Bio Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2013
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by CG Bio Co., Ltd.
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 08, 2025
COLONNADE Posterior Screw Fixation System
K250582
·
NKB
Orthopedic
·
70d
Cleared
May 25, 2023
Advanced LumFix Spinal Fixation System
K222229
·
NKB
Orthopedic
·
304d
Cleared
Oct 04, 2016
LumFix Spinal Fixation Sytem
K160731
·
MNI
Orthopedic
·
201d
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4
Orthopedic
3
General & Plastic Surgery
1