Medical Device Manufacturer · US , Tallahassee , FL

Vy Spine, LLC - FDA 510(k) Cleared Devices

21 submissions · 21 cleared · Since 2021

Recent clearances: VyPlate™ Anterior Cervical Plate System, DiversiVy™ Facet Screw System, VyBrate™ VBR System

21
Total
21
Cleared
0
Denied

FDA 510(k) Regulatory Record - Vy Spine, LLC Orthopedic

21 devices
1-21 of 21
Cleared Mar 27, 2026
VyPlate™ Anterior Cervical Plate System
K260697 · KWQ
Orthopedic · 23d
Cleared Mar 19, 2026
DiversiVy™ Facet Screw System
K253432 · MRW
Orthopedic · 169d
Cleared Jan 07, 2026
VyBrate™ VBR System
K253158 · MQP
Orthopedic · 103d
Cleared Mar 18, 2025
FortiVy™ OsteoVy™ Lumbar IBF
K241783 · MAX
Orthopedic · 271d
Cleared Oct 16, 2024
Vy Spine™ VyLam™ Laminoplasty System
K242784 · NQW
Orthopedic · 30d
Cleared Sep 24, 2024
LumiVy™ Lumbar IBF System
K233807 · MAX
Orthopedic · 300d
Cleared Oct 30, 2023
ClariVy™ Cervical IBF System
K231836 · ODP
Orthopedic · 130d
Cleared Oct 13, 2023
VyLink™ Spinal Screw System
K231744 · NKB
Orthopedic · 121d
Cleared Oct 10, 2023
Vy Spine™ VyLam™ Laminoplasty System
K232471 · NQW
Orthopedic · 55d
Cleared Sep 27, 2023
VySpan™ PCT System
K232167 · NKG
Orthopedic · 68d
Cleared May 12, 2023
ClariVy™ Cervical IBF System
K230414 · ODP
Orthopedic · 85d
Cleared Apr 18, 2023
UniVy™ OsteoVy™-Ti Cervical IBF System
K223513 · ODP
Orthopedic · 147d
Cleared Feb 24, 2023
VySpan™ PCT System
K223852 · NKG
Orthopedic · 64d
Cleared Jan 06, 2023
LumiVy™ Lumbar IBF System
K223412 · MAX
Orthopedic · 58d
Cleared Nov 04, 2022
UniVy OsteoVy Cervical IBF System
K221162 · ODP
Orthopedic · 196d
Cleared Jul 26, 2022
VyPlate Anterior Cervical Plate System
K221572 · KWQ
Orthopedic · 55d
Cleared Feb 28, 2022
VyLink™ Spinal Screw System
K213750 · NKB
Orthopedic · 90d
Cleared Feb 16, 2022
LumiVy Lumbar IBF System
K212930 · MAX
Orthopedic · 155d
Cleared Dec 23, 2021
Vy Spine™ VyWasher™ Buttress System
K213219 · KWQ
Orthopedic · 85d
Cleared Dec 20, 2021
Vy Spine ClariVy Cervical IBF System
K212715 · ODP
Orthopedic · 116d
Cleared Dec 10, 2021
Vy Spine™ VySpan™ PCT System
K213394 · NKG
Orthopedic · 56d
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