DiversiVy Facet Screw System
FDA 510(k) K253432 · Vy Spine, LLC
510(k) numberK253432
Submission
- Device name
- DiversiVy Facet Screw System
- Applicant
- Vy Spine, LLC
Bountiful, UT, US - Received
- October 1, 2025
- Decision date
- March 19, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRW – System, Facet Screw Spinal Device
- Device class
- Unclassified
- Implant
- Yes
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| K261209 | Ion-LMRW · Traditional | SurGenTec, LLC | 06/11/2026SE |
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| 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 |
| K251885 | CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX ImplantMRW · Special | Providence Medical Technology, Inc. | 07/10/2025SE |
| 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 |
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Questions and answers
When was DiversiVy Facet Screw System cleared by the FDA?
DiversiVy Facet Screw System (K253432) received a 510(k) decision of Substantially Equivalent on March 19, 2026, 169 days after the submission was received.
What is the product code of K253432?
The FDA product code is MRW – System, Facet Screw Spinal Device, a Unclassified device.