Dio Medical Co., Ltd.
Medical device manufacturer in East Norriton, PA.
13510(k) clearances
0PMA approvals
0recalls
Device types
- KWQ Appliance, Fixation, Spinal Intervertebral… 2
- ODP Intervertebral Fusion Device With Bone… 2
- PEK Spinous Process Plate 2
- MNI Orthosis, Spinal Pedicle Fixation 1
- MNH Orthosis, Spondylolisthesis Spinal Fixation 1
- KWP Appliance, Fixation, Spinal Interlaminal 1
- MRW System, Facet Screw Spinal Device 1
- OUR Sacroiliac Joint Fixation 1
- NKB Thoracolumbosacral Pedicle Screw System 1
- OVE Intervertebral Fusion Device With… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K223790 | Huvex Interspinous Fusion SystemPEK · Traditional | 03/09/2023SE |
| K223140 | AEON-C Stand Alone SystemOVE · Traditional | 12/20/2022SE |
| K222415 | Rexious Spinal Fixation SystemNKB · Traditional | 10/25/2022SE |
| K222572 | FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…KWQ · Traditional | 10/18/2022SE |
| K222448 | UNITY Sacroiliac Joint Fixation SystemOUR · Traditional | 10/13/2022SE |
| K222515 | FaSet Fixation SystemMRW · Traditional | 10/05/2022SE |
| K162849 | Huvex Interspinous Fixation SystemPEK · Traditional | 02/16/2017SE |
| K162220 | DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageODP · Traditional | 11/21/2016SE |
| K122872 | Intervertebral Body Fusion DeviceODP · Traditional | 02/28/2013SE |
| K121862 | Rex Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2012SE |
| K113324 | Rexious Hook Fixation SystemsKWP · Traditional | 03/28/2012SE |
| K111362 | Rexious Spinal Fixation SystemMNH · Special | 07/21/2011SE |
| K100765 | Fixpine II SystemMNI · Traditional | 07/19/2010SE |