510k
Database
Specialties
Anesthesiology
136
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572
Chemistry
165
Dental
320
Ear, Nose, Throat
68
Gastroenterology & Urology
291
General & Plastic Surgery
526
General Hospital
379
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67
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57
Medical Genetics
0
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234
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173
Obstetrics & Gynecology
62
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51
Orthopedic
1296
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18
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88
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876
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88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
LNH
System, Nuclear Magnetic...
83
MAX
Intervertebral Fusion Device...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Surgentec
Medical Device Manufacturer
·
US , Boca Raton , FL
Surgentec - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2020
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Surgentec
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Aug 03, 2023
TiLink-L Joint Fusion System
K231831
·
OUR
Orthopedic
·
42d
Cleared
Sep 03, 2020
3D GraftRasp System
K201900
·
FMF
Orthopedic
·
57d
Filters
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3
Orthopedic
2
General & Plastic Surgery
1