510k
Database
Specialties
Anesthesiology
538
Cardiovascular
1654
Chemistry
360
Dental
1323
Ear, Nose, Throat
243
Gastroenterology & Urology
957
General & Plastic Surgery
2175
General Hospital
2038
Hematology
126
Immunology
97
Medical Genetics
8
Microbiology
462
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958
Obstetrics & Gynecology
433
Ophthalmic
274
Orthopedic
2828
Pathology
52
Physical Medicine
515
Radiology
2403
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
407
LLZ
System, Image Processing,...
381
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
351
GEI
Electrosurgical, Cutting &...
301
IYN
System, Imaging, Pulsed Doppler,...
284
QIH
Automated Radiological Image...
275
HRS
Plate, Fixation, Bone
269
OLO
Orthopedic Stereotaxic Instrument
226
MAX
Intervertebral Fusion Device...
209
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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) Regulatory Record - 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