510k
Database
Specialties
Anesthesiology
133
Cardiovascular
569
Chemistry
164
Dental
314
Ear, Nose, Throat
68
Gastroenterology & Urology
288
General & Plastic Surgery
516
General Hospital
373
Hematology
67
Immunology
56
Medical Genetics
0
Microbiology
233
Neurology
167
Obstetrics & Gynecology
61
Ophthalmic
49
Orthopedic
1293
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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Innosys Co., Ltd.
Medical Device Manufacturer
·
KR , Uijeongbu-Si
Innosys Co., Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2023
4
Total
4
Cleared
0
Denied
FDA 510(k) cleared devices by Innosys Co., Ltd.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Jun 14, 2024
INNOVERSE Navigation Instruments
K241082
·
OLO
Orthopedic
·
56d
Cleared
Apr 19, 2024
UniSpace® Stand-Alone C Cage
K234119
·
OVE
Orthopedic
·
113d
Cleared
Feb 06, 2024
INNOVERSE Spinal System
K233960
·
NKB
Orthopedic
·
53d
Cleared
Oct 26, 2023
ANAX™ 5.5 Spinal System
K231737
·
NKB
Orthopedic
·
134d
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4
Orthopedic
4