Total clearances
6
2022-10-05 → 2023-03-09
Name variants in FDA filings: Dio Medical, Inc. / Dio Medical Corporation / Dio Medical Corp.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| PEK |
Spinous Process Plate |
Class II |
Orthopedic |
1 |
2023-03-09 |
| OVE |
Intervertebral Fusion Device With Integrated Fixation, Cervical |
Class II |
Orthopedic |
1 |
2022-12-20 |
| NKB |
Thoracolumbosacral Pedicle Screw System |
Class II |
Orthopedic |
1 |
2022-10-25 |
| KWQ |
Appliance, Fixation, Spinal Intervertebral Body |
Class II |
Orthopedic |
1 |
2022-10-18 |
| OUR |
Sacroiliac Joint Fixation |
Class II |
Orthopedic |
1 |
2022-10-13 |
| MRW |
System, Facet Screw Spinal Device |
Unclassified |
Unknown |
1 |
2022-10-05 |
Filings
All 510(k) clearances (6)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2023-03-09 |
K223790 |
Huvex Interspinous Fusion System |
PEK |
Class II |
Orthopedic |
| 2022-12-20 |
K223140 |
AEON-C Stand Alone System |
OVE |
Class II |
Orthopedic |
| 2022-10-25 |
K222415 |
Rexious Spinal Fixation System |
NKB |
Class II |
Orthopedic |
| 2022-10-18 |
K222572 |
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System |
KWQ |
Class II |
Orthopedic |
| 2022-10-13 |
K222448 |
UNITY Sacroiliac Joint Fixation System |
OUR |
Class II |
Orthopedic |
| 2022-10-05 |
K222515 |
FaSet Fixation System |
MRW |
Unclassified |
Unknown |