# Vy Spine, LLC

- Location (FDA's records): Tallahassee, FL
- FDA decisions: 21 (2021–2026): 21 510(k) clearances
- Product codes: ODP (5), MAX (4), NKG (3), KWQ (3), NQW (2), NKB (2), MQP (1), MRW (1)
- 510(k) review time since 2016: median 103 days, against 88 for FDA's reviews in the same codes and years (7 of 19 faster)
- Predicates its devices cite: 55 (19 its own); citations of its devices by later devices: 20 (19 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Reliance Medical Systems, LLC: 16 (https://510kreport.com/company/reliance-medical-systems)
- SeaSpine Orthopedics Corporation: 7 (https://510kreport.com/company/seaspine-orthopedics)
- Rti Surgical, Inc.: 2 (https://510kreport.com/company/rti-surgical)
- Nexxt Spine, LLC: 2 (https://510kreport.com/company/nexxt-spine)
- Seaspine, Inc.: 1 (https://510kreport.com/company/seaspine)
- Synthes Spine: 1 (https://510kreport.com/company/synthes-spine)
- Biomet Spine (Aka Ebi, LLC): 1 (https://510kreport.com/company/biomet-spine-aka-ebi)
- Oxford Performance Materials, Inc.: 1 (https://510kreport.com/company/oxford-performance-materials)

## Firms that cite its devices most
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)

## Its most-cited devices
- K212715: Vy Spine ClariVy Cervical IBF System (2021), cited by 4
- K223412: LumiVy™ Lumbar IBF System (2023), cited by 3
- K212930: LumiVy Lumbar IBF System (2022), cited by 2
- K230414: ClariVy™ Cervical IBF System (2023), cited by 2
- K233807: LumiVy™ Lumbar IBF System (2024), cited by 1
- K221162: UniVy OsteoVy Cervical IBF System (2022), cited by 1

## Recent decisions
- K260697: VyPlate™ Anterior Cervical Plate System (Mar 27, 2026)
- K253432: DiversiVy™ Facet Screw System (Mar 19, 2026)
- K253158: VyBrate™ VBR System (Jan 7, 2026)
- K241783: FortiVy™ OsteoVy™ Lumbar IBF (Mar 18, 2025)
- K242784: Vy Spine™ VyLam™ Laminoplasty System (Oct 16, 2024)
- K233807: LumiVy™ Lumbar IBF System (Sep 24, 2024)
- K231836: ClariVy™ Cervical IBF System (Oct 30, 2023)
- K231744: VyLink™ Spinal Screw System (Oct 13, 2023)

Source page: https://510kreport.com/company/vy-spine