RIGEL 3DR Anterior Cervical Corpectomy System
FDA 510(k) K232481 · MiRus, LLC
510(k) numberK232481
Submission
- Device name
- RIGEL 3DR Anterior Cervical Corpectomy System
- Applicant
- MiRus, LLC
Marietta, GA, US - Received
- August 16, 2023
- Decision date
- October 13, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLR – Spinal Vertebral Body Replacement Device - Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Vertebral body replacement in the cervical spine.
Other 510(k)s with product code PLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252822 | Atlas Spine HiRISE Expandable Cervical-p Corpectomy ImplantPLR · Traditional | Atlas Spine, Inc. | 07/15/2026SE |
| K252560 | Atlas Spine HiRISE Expandable Cervical Corpectomy SystemPLR · Traditional | Atlas Spine, Inc. | 11/10/2025SE |
| K221542 | Galileo Vertebral Body Replacement DevicePLR · Special | Bright Spine | 01/13/2023SE |
| K212126 | MediExpand Cervical Expandable VBR SystemPLR · Traditional | Cmf Medicon Surgical, Inc. | 04/04/2022SE |
| K211320 | CAPRI Corpectomy Cage SystemPLR · Traditional | K2m, Inc. | 02/24/2022SE |
| K192145 | Galileo Vertebral Body Replacement DevicePLR · Traditional | Bright Spine | 04/21/2020SE |
| K193412 | NEXXT MATRIXX SystemPLR · Traditional | Nexxt Spine, LLC | 02/24/2020SE |
| K190284 | Bengal Stackable Cage SystemPLR · Traditional | Medos International SARL | 12/20/2019SE |
| K190426 | ALTA Anterior Cervical Corpectomy SystemPLR · Traditional | Astura Medical, LLC | 10/24/2019SE |
| K191778 | Omnia Medical VBRPLR · Special | Omnia Medical, LLC | 08/28/2019SE |
More from Omnia Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253444 | EUROPA Posterior Cervical Fusion Navigated InstrumentsOLO · Traditional | 03/18/2026SE |
| K252733 | ATLAS Expandable Osteotomy Wedge SystemPLF · Traditional | 02/19/2026SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | 11/19/2024SE |
| K241175 | MiRus MoRe Lumbar Plating SystemKWQ · Traditional | 05/17/2024SE |
| K232348 | RIGEL 3DR Standalone Anterior Cervical Interbody Fusion SystemOVE · Traditional | 10/27/2023SE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate FixationOVD · Traditional | 09/11/2023SE |
| K230369 | EUROPA Navigated InstrumentsOLO · Traditional | 06/23/2023SE |
| K220441 | CYGNUS MoRe Anterior Cervical Plate SystemKWQ · Traditional | 09/16/2022SE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 05/13/2022SE |
| K210800 | IO Expandable Lumbar Interbody Fusion SystemMAX · Traditional | 08/20/2021SE |
Questions and answers
When was RIGEL 3DR Anterior Cervical Corpectomy System cleared by the FDA?
RIGEL 3DR Anterior Cervical Corpectomy System (K232481) received a 510(k) decision of Substantially Equivalent on October 13, 2023, 58 days after the submission was received.
What is the product code of K232481?
The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.