510k
Database
Specialties
Anesthesiology
204
Cardiovascular
737
Chemistry
187
Dental
465
Ear, Nose, Throat
91
Gastroenterology & Urology
393
General & Plastic Surgery
769
General Hospital
475
Hematology
77
Immunology
64
Medical Genetics
1
Microbiology
277
Neurology
297
Obstetrics & Gynecology
116
Ophthalmic
77
Orthopedic
1476
Pathology
26
Physical Medicine
152
Radiology
1085
Toxicology
93
Categories
IYN
System, Imaging, Pulsed Doppler,...
167
HRS
Plate, Fixation, Bone
151
OLO
Orthopedic Stereotaxic Instrument
130
GEX
Powered Laser Surgical Instrument
125
LLZ
System, Image Processing,...
123
QIH
Automated Radiological Image...
109
NHA
Abutment, Implant, Dental,...
105
GEI
Electrosurgical, Cutting &...
105
MAX
Intervertebral Fusion Device...
96
MBI
Fastener, Fixation,...
93
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Trans1
Medical Device Manufacturer
·
US , Wilmington , NC
Trans1 - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2019
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Trans1
Orthopedic
✕
2
devices
1-2 of 2
Filters
Cleared
Nov 20, 2019
TranS1 AxiaLIF Plus System
K192792
·
KWQ
Orthopedic
·
51d
Cleared
Sep 25, 2019
TranS1 Interbody Fusion System
K191791
·
MAX
Orthopedic
·
84d
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Orthopedic
2