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
MBI
Fastener, Fixation,...
77
NKB
Thoracolumbosacral Pedicle Screw...
77
LNH
System, Nuclear Magnetic...
76
JAK
System, X-ray, Tomography, Computed
73
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About
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Orthofix Srl
Medical Device Manufacturer
·
US , Rockville , MD
Orthofix Srl - FDA 510(k) Cleared Devices
36 submissions
·
36 cleared
·
Since 1995
36
Total
36
Cleared
0
Denied
FDA 510(k) cleared devices by Orthofix Srl
Radiology
✕
2
devices
1-2 of 2
Filters
Cleared
Dec 19, 2024
OrthoNext Platform System
K242270
·
QIH
Radiology
·
140d
Cleared
Oct 27, 2020
OrthoNext Platform System
K202519
·
LLZ
Radiology
·
56d
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36
Orthopedic
34
Radiology
2