Data / Medical devices / United States / Vy Spine, LLC
Vy Spine, LLC: FDA-registered device maker in Bountiful, UT, United States, 24 510(k) clearances
Vy Spine, LLC is registered with the FDA (registration 3019837678) in Bountiful, UT, United States. It lists 15 device types. The FDA files 24 510(k) clearances under its listings, the newest dated March 27, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019837678
- Address
- 545 West 500 South Suite 100 & 110, Bountiful, UT, United States, 84010
- Owner or operator
- Vy Spine, LLC (10082347)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 14, 2021
- Registered through
- 2026
- Brand names listed
- ClariVy, ClariVy Cervical IBF System, ClariVy NanoVy Ti Cervical IBF System, ClariVy OsteoVy PEKK Cervical IBF System, DiversiVy Facet Screw System, FortiVy OsteoVy Ti Lumbar IBF System, FortiVy OsteoVy Ti NanoVy HA Lumbar IBF System, LumiVy Lumbar IBF System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 27, 2026 | K260697 | VyPlate Anterior Cervical Plate System | KWQ | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| March 19, 2026 | K253432 | DiversiVy Facet Screw System | MRW | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| March 18, 2025 | K241783 | FortiVy OsteoVy Lumbar IBF | MAX | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| October 16, 2024 | K242784 | Vy Spine VyLam Laminoplasty System | NQW | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| September 24, 2024 | K233807 | LumiVy Lumbar IBF System | MAX | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| October 30, 2023 | K231836 | ClariVy Cervical IBF System | ODP | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| October 13, 2023 | K231744 | VyLink Spinal Screw System | NKB | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| October 10, 2023 | K232471 | Vy Spine VyLam Laminoplasty System | NQW | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| September 27, 2023 | K232167 | VySpan PCT System | NKG | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| May 12, 2023 | K230414 | ClariVy Cervical IBF System | ODP | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| April 18, 2023 | K223513 | UniVy OsteoVy-Ti Cervical IBF System | ODP | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| February 24, 2023 | K223852 | VySpan PCT System | NKG | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| January 6, 2023 | K223412 | LumiVy Lumbar IBF System | MAX | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| November 4, 2022 | K221162 | UniVy OsteoVy Cervical IBF System | ODP | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| July 26, 2022 | K221572 | VyPlate Anterior Cervical Plate System | KWQ | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| February 28, 2022 | K213750 | VyLink Spinal Screw System | NKB | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| February 16, 2022 | K212930 | LumiVy Lumbar IBF System | MAX | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| December 23, 2021 | K213219 | Vy Spine VyWasher Buttress System | KWQ | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| December 20, 2021 | K212715 | Vy Spine ClariVy Cervical IBF System | ODP | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| December 10, 2021 | K213394 | Vy Spine VySpan PCT System | NKG | Substantially Equivalent | Vy Spine, LLC | accessdata.fda.gov |
| December 29, 2017 | K173102 | Reliance Cervical IBF System | ODP | Substantially Equivalent | Reliance Medical Systems, LLC | accessdata.fda.gov |
| September 17, 2015 | K152131 | Reliance Spinal Screw System | MNI | Substantially Equivalent | Reliance Medical Systems, LLC | accessdata.fda.gov |
| June 9, 2015 | K142269 | Reliance Cervical IBF System | ODP | Substantially Equivalent | Reliance Medical Systems, LLC | accessdata.fda.gov |
| April 29, 2015 | K142867 | Reliance Posterior Cervical-Thoracic System | KWP | Substantially Equivalent | Reliance Medical Systems, LLC | accessdata.fda.gov |
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Updated March 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.