Huvex Interspinous Fusion System
FDA 510(k) K223790 · Dio Medical Corp.
510(k) numberK223790
Submission
- Device name
- Huvex Interspinous Fusion System
- Applicant
- Dio Medical Corp.
East Norriton, PA, US - Received
- December 19, 2022
- Decision date
- March 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
Other 510(k)s with product code PEK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253250 | Minuteman® G6 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 12/01/2025SE |
| K234051 | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | Spinal Simplicity, LLC | 01/18/2024SE |
| K233527 | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion…PEK · Special | Spinal Simplicity, LLC | 11/29/2023SE |
| K232484 | KeyLift Expandable Interlaminar Stabilization SystemPEK · Traditional | Amplio Spine, LLC | 10/19/2023SE |
| K231807 | primaLOK SP Interspinous Fusion SystemPEK · Traditional | Wenzel Spine, Inc. | 08/15/2023SE |
| K221023 | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA…PEK · Traditional | Spinal Simplicity, LLC | 08/19/2022SE |
| K221399 | ZIP MIS Interspinous Fusion SystemPEK · Traditional | Aurora Spine, Inc. | 07/08/2022SE |
| K211880 | Minuteman G5 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 03/11/2022SE |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…PEK · Traditional | Spinal Simplicity, LLC | 12/15/2021SE |
| K213266 | Inspan ScrewLES Fusion SystemPEK · Traditional | Lespine Innovations, LLC | 12/03/2021SE |
More from Lespine Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
Questions and answers
When was Huvex Interspinous Fusion System cleared by the FDA?
Huvex Interspinous Fusion System (K223790) received a 510(k) decision of Substantially Equivalent on March 9, 2023, 80 days after the submission was received.
What is the product code of K223790?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.