510k
Database
Specialties
Anesthesiology
136
Cardiovascular
573
Chemistry
165
Dental
321
Ear, Nose, Throat
68
Gastroenterology & Urology
292
General & Plastic Surgery
529
General Hospital
379
Hematology
67
Immunology
58
Medical Genetics
0
Microbiology
234
Neurology
173
Obstetrics & Gynecology
64
Ophthalmic
51
Orthopedic
1298
Pathology
18
Physical Medicine
88
Radiology
879
Toxicology
88
Categories
IYN
System, Imaging, Pulsed Doppler,...
152
HRS
Plate, Fixation, Bone
134
OLO
Orthopedic Stereotaxic Instrument
117
LLZ
System, Image Processing,...
100
NHA
Abutment, Implant, Dental,...
86
MBI
Fastener, Fixation,...
85
MAX
Intervertebral Fusion Device...
84
LNH
System, Nuclear Magnetic...
83
NKB
Thoracolumbosacral Pedicle Screw...
81
JAK
System, X-ray, Tomography, Computed
79
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Coligne AG
Medical Device Manufacturer
·
CH , Zurich
Coligne AG - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2017
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Coligne AG
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
May 19, 2021
GII Spinal Fixation System
K210306
·
NKB
Orthopedic
·
105d
Cleared
Nov 14, 2018
ostaPek Interbody Fusion Cages
K181963
·
MAX
Orthopedic
·
114d
Cleared
Sep 06, 2018
Trabis
K173893
·
PLR
Orthopedic
·
259d
Cleared
Dec 01, 2017
ACIF
K173148
·
ODP
Orthopedic
·
63d
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4
Orthopedic
4