Company · US
Dio Medical Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2023. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| PEK | Spinous Process Plate | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 9, 2023 | K223790 | Huvex Interspinous Fusion System Dio Medical Corp. | PEK |
| Dec 20, 2022 | K223140 | AEON-C Stand Alone System Dio Medical, Inc. | OVE |
| Oct 25, 2022 | K222415 | Rexious Spinal Fixation System Dio Medical Corporation | NKB |
| Oct 18, 2022 | K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar P Dio Medical Corporation | KWQ |
| Oct 13, 2022 | K222448 | UNITY Sacroiliac Joint Fixation System Dio Medical Corporation | OUR |
| Oct 5, 2022 | K222515 | FaSet Fixation System Dio Medical Corporation | MRW |
| Feb 16, 2017 | K162849 | Huvex Interspinous Fixation System Dio Medical Co., Ltd., KR | PEK |
| Nov 21, 2016 | K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage Dio Medical Co., Ltd., KR | ODP |
| Feb 28, 2013 | K122872 | INTERVERTEBRAL BODY FUSION DEVICE Dio Medical Co., Ltd. | ODP |
| Oct 31, 2012 | K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM Dio Medical Co., Ltd. | KWQ |
| Mar 28, 2012 | K113324 | REXIOUS HOOK FIXATION SYSTEMS Dio Medical Co., Ltd. | KWP |
| Jul 21, 2011 | K111362 | REXIOUS SPINAL FIXATION SYSTEM Dio Medical Co., Ltd. | MNH |
| Jul 19, 2010 | K100765 | FIXPINE II SYSTEM Dio Medical Co., Ltd. | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||