Dio Medical Co., Ltd.
Santa Fe Springs, CA, US
Dio Medical Co., Ltd. appears in FDA device records in Santa Fe Springs, CA. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Dio Medical Co., Ltd. between 2010 and 2023. The busiest year on record is 2022, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 5 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223790 | Huvex Interspinous Fusion System | PEK | Substantially Equivalent | |
| K223140 | AEON-C™ Stand Alone System | OVE | Substantially Equivalent | |
| K222415 | Rexious Spinal Fixation System | NKB | Substantially Equivalent | |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System | KWQ | Substantially Equivalent | |
| K222448 | UNITY Sacroiliac Joint Fixation System | OUR | Substantially Equivalent | |
| K222515 | FaSet Fixation System | MRW | Substantially Equivalent | |
| K162849 | Huvex Interspinous Fixation System | PEK | Substantially Equivalent | |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage | ODP | Substantially Equivalent | |
| K122872 | INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K121862 | REX ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K113324 | REXIOUS HOOK FIXATION SYSTEMS | KWP | Substantially Equivalent | |
| K111362 | REXIOUS SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K100765 | FIXPINE II SYSTEM | MNI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- OURSacroiliac Joint Fixation
- PEKSpinous Process Plate
- MRWSystem, Facet Screw Spinal Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain