VyBrate VBR System
FDA 510(k) K253158 · Vy Spine, LLC
510(k) numberK253158
Submission
- Device name
- VyBrate VBR System
- Applicant
- Vy Spine, LLC
Bountiful, UT, US - Received
- September 26, 2025
- Decision date
- January 7, 2026
- 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 |
| 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 |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| 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 |
|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | 03/27/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | 03/19/2026SE |
| K241783 | FortiVy OsteoVy Lumbar IBFMAX · Traditional | 03/18/2025SE |
| K242784 | Vy Spine VyLam Laminoplasty SystemNQW · Special | 10/16/2024SE |
| K233807 | LumiVy Lumbar IBF SystemMAX · Traditional | 09/24/2024SE |
| K231836 | ClariVy Cervical IBF SystemODP · Traditional | 10/30/2023SE |
| K231744 | VyLink Spinal Screw SystemNKB · Traditional | 10/13/2023SE |
| K232471 | Vy Spine VyLam Laminoplasty SystemNQW · Traditional | 10/10/2023SE |
| K232167 | VySpan PCT SystemNKG · Special | 09/27/2023SE |
| K230414 | ClariVy Cervical IBF SystemODP · Special | 05/12/2023SE |
Questions and answers
When was VyBrate VBR System cleared by the FDA?
VyBrate VBR System (K253158) received a 510(k) decision of Substantially Equivalent on January 7, 2026, 103 days after the submission was received.
What is the product code of K253158?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.