Company · US
Vy Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2021 to 2026. Name variants (Inc, Corp, punctuation) are merged.
21510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 |
| NKG | Posterior Cervical Screw System | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2026 | K260697 | VyPlate Anterior Cervical Plate System Vy Spine, LLC | KWQ |
| Mar 19, 2026 | K253432 | DiversiVy Facet Screw System Vy Spine, LLC | MRW |
| Jan 7, 2026 | K253158 | VyBrate VBR System Vy Spine, LLC | MQP |
| Mar 18, 2025 | K241783 | FortiVy OsteoVy Lumbar IBF Vy Spine, LLC | MAX |
| Oct 16, 2024 | K242784 | Vy Spine VyLam Laminoplasty System Vy Spine, LLC | NQW |
| Sep 24, 2024 | K233807 | LumiVy Lumbar IBF System Vy Spine, LLC | MAX |
| Oct 30, 2023 | K231836 | ClariVy Cervical IBF System Vy Spine, LLC | ODP |
| Oct 13, 2023 | K231744 | VyLink Spinal Screw System Vy Spine, LLC | NKB |
| Oct 10, 2023 | K232471 | Vy Spine VyLam Laminoplasty System Vy Spine, LLC | NQW |
| Sep 27, 2023 | K232167 | VySpan PCT System Vy Spine, LLC | NKG |
| May 12, 2023 | K230414 | ClariVy Cervical IBF System Vy Spine, LLC | ODP |
| Apr 18, 2023 | K223513 | UniVy OsteoVy-Ti Cervical IBF System Vy Spine, LLC | ODP |
| Feb 24, 2023 | K223852 | VySpan PCT System Vy Spine, LLC | NKG |
| Jan 6, 2023 | K223412 | LumiVy Lumbar IBF System Vy Spine, LLC | MAX |
| Nov 4, 2022 | K221162 | UniVy OsteoVy Cervical IBF System Vy Spine, LLC | ODP |
| Jul 26, 2022 | K221572 | VyPlate Anterior Cervical Plate System Vy Spine, LLC | KWQ |
| Feb 28, 2022 | K213750 | VyLink Spinal Screw System Vy Spine, LLC | NKB |
| Feb 16, 2022 | K212930 | LumiVy Lumbar IBF System Vy Spine, LLC | MAX |
| Dec 23, 2021 | K213219 | Vy Spine VyWasher Buttress System Vy Spine, LLC | KWQ |
| Dec 20, 2021 | K212715 | Vy Spine ClariVy Cervical IBF System Vy Spine, LLC | ODP |
| Dec 10, 2021 | K213394 | Vy Spine VySpan PCT System Vy Spine, LLC | NKG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||