Total clearances
5
2023-03-03 → 2024-06-14
Name variants in FDA filings: Innosys / Innosys Co., Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| NKB |
Thoracolumbosacral Pedicle Screw System |
Class II |
Orthopedic |
2 |
2024-02-06 |
| OLO |
Orthopedic Stereotaxic Instrument |
Class II |
Neurology |
1 |
2024-06-14 |
| OVE |
Intervertebral Fusion Device With Integrated Fixation, Cervical |
Class II |
Orthopedic |
1 |
2024-04-19 |
| HSB |
Rod, Fixation, Intramedullary And Accessories |
Class II |
Orthopedic |
1 |
2023-03-03 |
Filings
All 510(k) clearances (5)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2024-06-14 |
K241082 |
INNOVERSE Navigation Instruments |
OLO |
Class II |
Neurology |
| 2024-04-19 |
K234119 |
UniSpace® Stand-Alone C Cage |
OVE |
Class II |
Orthopedic |
| 2024-02-06 |
K233960 |
INNOVERSE Spinal System |
NKB |
Class II |
Orthopedic |
| 2023-10-26 |
K231737 |
ANAX 5.5 Spinal System |
NKB |
Class II |
Orthopedic |
| 2023-03-03 |
K221084 |
Dyna Locking Trochanteric Nail |
HSB |
Class II |
Orthopedic |