Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Vy Spine, LLC — Predicate Candidate Screening

21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time
196 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC2026-03-27230
K253432DiversiVy™ Facet Screw SystemVy Spine, LLC2026-03-191690
K253158VyBrate™ VBR SystemVy Spine, LLC2026-01-071030
K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC2025-03-182710
K242784Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC2024-10-16300
K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC2024-09-243000
K231836ClariVy™ Cervical IBF SystemVy Spine, LLC2023-10-301300
K231744VyLink™ Spinal Screw SystemVy Spine, LLC2023-10-131210
K232471Vy Spine™ VyLam™ Laminoplasty SystemVy Spine, LLC2023-10-10550
K232167VySpan™ PCT SystemVy Spine, LLC2023-09-27680
K230414ClariVy™ Cervical IBF SystemVy Spine, LLC2023-05-12850
K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC2023-04-181470
K223852VySpan™ PCT SystemVy Spine, LLC2023-02-24640
K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC2023-01-06580
K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC2022-11-041960
K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC2022-07-26550
K213750VyLink™ Spinal Screw SystemVy Spine, LLC2022-02-28900
K212930LumiVy Lumbar IBF SystemVy Spine, LLC2022-02-161550
K213219Vy Spine™ VyWasher™ Buttress SystemVy Spine, LLC2021-12-23850
K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC2021-12-201160
K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC2021-12-10560

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda