510k
Database
Specialties
Anesthesiology
140
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576
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
293
General & Plastic Surgery
533
General Hospital
380
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
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173
Obstetrics & Gynecology
66
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52
Orthopedic
1299
Pathology
18
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88
Radiology
883
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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,...
87
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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Ortoma AB
Medical Device Manufacturer
·
SE , Goteborg
Ortoma AB - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2018
3
Total
3
Cleared
0
Denied
FDA 510(k) cleared devices by Ortoma AB
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
May 16, 2025
OTS Hip
K250086
·
OLO
Orthopedic
·
123d
Cleared
Mar 11, 2024
OTS Hip
K232140
·
OLO
Orthopedic
·
237d
Cleared
Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449
·
OLO
Orthopedic
·
110d
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3
Orthopedic
3