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

Vy Spine, LLC develops and manufactures orthopedic spinal implants and surgical solutions. The company offers a comprehensive product portfolio spanning cervical, thoracic, lumbar, and sacroiliac spine applications. With a manufacturing facility in Tallahassee, US, Vy Spine combines core spine technologies with innovative materials and designs to address simple to complex surgical needs.

The company has received 21 FDA 510(k) clearances from 21 total submissions since its first clearance in 2021. All submissions have focused on orthopedic devices. The latest clearance in 2026 reflects continued regulatory activity and product development within the spinal implant market.

Vy Spine's cleared device portfolio includes anterior cervical plate systems, facet screw systems, vertebral body replacement systems, interbody fusion devices, laminoplasty systems, and percutaneous screw fixation systems. The company emphasizes proprietary technologies including OsteoVy™ 3D-printed lattice structures for osseointegration and NanoVy™ advanced nano coatings for implant performance.

Explore the complete list of Vy Spine, LLC FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.

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

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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