510k
Database
Specialties
Anesthesiology
134
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
289
General & Plastic Surgery
521
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
168
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1294
Pathology
18
Physical Medicine
86
Radiology
870
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
150
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
MBI
Fastener, Fixation,...
85
NHA
Abutment, Implant, Dental,...
84
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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Spintech, Inc.
Medical Device Manufacturer
·
US , Minneapolis , MN
Spintech, Inc. - FDA 510(k) Cleared Devices
10 submissions
·
10 cleared
·
Since 1992
10
Total
10
Cleared
0
Denied
FDA 510(k) cleared devices by Spintech, Inc.
Radiology
✕
3
devices
1-3 of 3
Filters
Cleared
Oct 28, 2022
Stage
K223079
·
LNH
Radiology
·
28d
Cleared
Jun 29, 2021
STAGE
K210843
·
LNH
Radiology
·
99d
Cleared
Feb 23, 2018
SPIN-SWI
K173224
·
LNH
Radiology
·
143d
Filters
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10
Dental
4
Radiology
3
General Hospital
2
Orthopedic
1