DOMINION Expandable Corpectomy System
FDA 510(k) K233359 · Astura Medical
510(k) numberK233359
Submission
- Device name
- DOMINION Expandable Corpectomy System
- Applicant
- Astura Medical
Irving, TX, US - Received
- September 29, 2023
- Decision date
- March 8, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | Icotec AG | 05/29/2020SE |
More from Icotec AG
| 510(k) | Device | Decision |
|---|---|---|
| K252885 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemPML · Traditional | 01/22/2026SE |
| K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemNKB · Traditional | 10/21/2025SE |
| K243259 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 01/07/2025SE |
| K240160 | EGPS Navigated InstrumentsOLO · Traditional | 10/17/2024SE |
| K231694 | MASADA Modular Spinal Fixation SystemNKB · Traditional | 11/16/2023SE |
| K232211 | REUNION Sacroiliac Joint Fusion SystemOUR · Traditional | 10/24/2023SE |
| K223335 | SIRION Lateral Lumbar Interbody SystemMAX · Traditional | 05/09/2023SE |
| K222097 | OLYMPIC Deformity Band SystemOWI · Traditional | 05/04/2023SE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody FusionOVD · Traditional | 01/19/2023SE |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion SystemOVD · Traditional | 03/30/2022SE |
Questions and answers
When was DOMINION Expandable Corpectomy System cleared by the FDA?
DOMINION Expandable Corpectomy System (K233359) received a 510(k) decision of Substantially Equivalent on March 8, 2024, 161 days after the submission was received.
What is the product code of K233359?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.