Vy Spine, LLC: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Vy Spine, LLC” (first 2021, latest 2026), across 8 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 88 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 3 | 85 |
| 2022 | 4 | 122 |
| 2023 | 8 | 76 |
| 2024 | 2 | 165 |
| 2025 | 1 | 271 |
| 2026 | 3 | 103 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vy Spine, LLC took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| NKG | Posterior Cervical Screw System | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
Review panels
- Orthopedic (21)
Most recent Vy Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260697 | VyPlate Anterior Cervical Plate System | KWQ | 2026-03-27 | 23 |
| K253432 | DiversiVy Facet Screw System | MRW | 2026-03-19 | 169 |
| K253158 | VyBrate VBR System | MQP | 2026-01-07 | 103 |
| K241783 | FortiVy OsteoVy Lumbar IBF | MAX | 2025-03-18 | 271 |
| K242784 | Vy Spine VyLam Laminoplasty System | NQW | 2024-10-16 | 30 |
| K233807 | LumiVy Lumbar IBF System | MAX | 2024-09-24 | 300 |
| K231836 | ClariVy Cervical IBF System | ODP | 2023-10-30 | 130 |
| K231744 | VyLink Spinal Screw System | NKB | 2023-10-13 | 121 |
| K232471 | Vy Spine VyLam Laminoplasty System | NQW | 2023-10-10 | 55 |
| K232167 | VySpan PCT System | NKG | 2023-09-27 | 68 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vy Spine, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Vy Spine, LLC?
FDA lists 21 510(k) clearances under the applicant name “Vy Spine, LLC” (first 2021, latest 2026), across 8 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Vy Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vy Spine, LLC is 90 days. Since 2017: 90 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vy Spine, LLC?
The most frequent FDA product codes under this applicant name are 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).
Next steps
- See all 21 Vy Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code ODP, Vy Spine, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.