CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
FDA 510(k) K251885 · Providence Medical Technology, Inc.
510(k) numberK251885
Submission
- Device name
- CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant
- Applicant
- Providence Medical Technology, Inc.
Pleasanton, CA, US - Received
- June 20, 2025
- Decision date
- July 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code MRW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261209 | Ion-LMRW · Traditional | SurGenTec, LLC | 06/11/2026SE |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)MRW · Traditional | Providence Medical Technology, Inc. | 05/14/2026SE |
| K253432 | DiversiVy Facet Screw SystemMRW · Traditional | Vy Spine, LLC | 03/19/2026SE |
| K251714 | Ion-CMRW · Traditional | SurGenTec, LLC | 01/16/2026SE |
| K250679 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 12/04/2025SE |
| K253190 | CORUS-LX ImplantMRW · Traditional | Providence Medical Technology, Inc. | 11/20/2025SE |
| K252153 | FFX Facet Fixation SystemMRW · Traditional | Sc Medica | 10/16/2025SE |
| K250920 | Arthrex Spine Compression FT ScrewMRW · Traditional | Arthrex, Inc. | 05/22/2025SE |
| K242527 | The Karma® Fixation SystemMRW · Traditional | Spinal Elements, Inc. | 05/21/2025SE |
| K243865 | AERO MIS Facet Fusion SystemMRW · Traditional | Aurora Spine | 03/24/2025SE |
More from Aurora Spine
| 510(k) | Device | Decision |
|---|---|---|
| K261665 | CORUS Navigation System-GNOLO · Special | 06/18/2026SE |
| K253676 | CORUS Posterior Cervical Stabilization System 3D (CORUS PCSS 3D)MRW · Traditional | 05/14/2026SE |
| K253190 | CORUS-LX ImplantMRW · Traditional | 11/20/2025SE |
| K251060 | CORUS Navigation System-GXOLO · Traditional | 07/30/2025SE |
| K241035 | PMT Posterior Cervical Stabilization System (PCSS)MRW · Traditional | 06/25/2024SE |
| K240625 | CORUS Navigation Access SystemOLO · Traditional | 05/03/2024SE |
| K230840 | PMT Facet Fixation System, Lumbar (PMT FFS-LX)MRW · Traditional | 12/19/2023SE |
| K230297 | PMT Expandable Cage (PMT EXP)MRW · Traditional | 08/11/2023SE |
| K220951 | PMT Facet Fixation System (PMT FFS)MRW · Traditional | 12/09/2022SE |
| K212636 | CORUS Spinal System-XHRX · Traditional | 10/15/2021SE |
Questions and answers
When was CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant cleared by the FDA?
CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (K251885) received a 510(k) decision of Substantially Equivalent on July 10, 2025, 20 days after the submission was received.
What is the product code of K251885?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.