510k
Database
Specialties
Anesthesiology
133
Cardiovascular
568
Chemistry
163
Dental
313
Ear, Nose, Throat
68
Gastroenterology & Urology
287
General & Plastic Surgery
514
General Hospital
371
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
232
Neurology
164
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1291
Pathology
18
Physical Medicine
85
Radiology
867
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
MAX
Intervertebral Fusion Device...
83
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Spiway, LLC
Medical Device Manufacturer
·
US , Laguna Beach , CA
Spiway, LLC - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2014
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Spiway, LLC
Ear, Nose, Throat
✕
4
devices
1-4 of 4
Filters
Cleared
Oct 27, 2021
SPIWay Endonasal Access Guide
K213153
·
LYA
Ear, Nose, Throat
·
29d
Cleared
Feb 16, 2018
SPIWay Endonasal Access Guide
K180141
·
LYA
Ear, Nose, Throat
·
29d
Cleared
Jan 28, 2016
SPIWay Endonasal Access Guide
K153686
·
LYA
Ear, Nose, Throat
·
36d
Cleared
Jan 29, 2014
SPIWAY ENDONASAL ACCESS GUIDE
K132721
·
LYA
Ear, Nose, Throat
·
152d
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4
Ear, Nose, Throat
4