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
868
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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Spinevision, S.A.S.
Medical Device Manufacturer
·
FR , Antony
Spinevision, S.A.S. - FDA 510(k) Cleared Devices
5 submissions
·
5 cleared
·
Since 2018
5
Total
5
Cleared
0
Denied
FDA 510(k) cleared devices by Spinevision, S.A.S.
Orthopedic
✕
5
devices
1-5 of 5
Filters
Cleared
Dec 16, 2022
Hexanium PLIF
K223251
·
MAX
Orthopedic
·
56d
Cleared
Nov 14, 2022
Hexanium ACIF
K221578
·
OVE
Orthopedic
·
166d
Cleared
Mar 10, 2021
Hexanium TLIF
K210359
·
MAX
Orthopedic
·
30d
Cleared
Oct 20, 2020
Hexanium® ACIF
K193000
·
OVE
Orthopedic
·
358d
Cleared
May 04, 2018
Hexanium® TLIF
K180437
·
MAX
Orthopedic
·
73d
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Orthopedic
5