510k
Database
Specialties
Anesthesiology
141
Cardiovascular
579
Chemistry
167
Dental
324
Ear, Nose, Throat
68
Gastroenterology & Urology
296
General & Plastic Surgery
536
General Hospital
384
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
67
Ophthalmic
52
Orthopedic
1303
Pathology
18
Physical Medicine
88
Radiology
887
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
136
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
87
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
NKB
Thoracolumbosacral Pedicle Screw...
83
LNH
System, Nuclear Magnetic...
83
JAK
System, X-ray, Tomography, Computed
79
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Orthocell, Ltd.
Medical Device Manufacturer
·
AU , Perth
Orthocell, Ltd. - FDA 510(k) Cleared Devices
2 submissions
·
2 cleared
·
Since 2021
2
Total
2
Cleared
0
Denied
FDA 510(k) cleared devices by Orthocell, Ltd.
Dental
✕
1
devices
1-1 of 1
Filters
Cleared
Jan 11, 2021
Striate+™
K201241
·
NPL
Dental
·
248d
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2
Neurology
1
Dental
1