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510(k) K213750

VyLink™ Spinal Screw System by Vy Spine, LLC — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2022
Date Received
November 30, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Vy Spine, LLC

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  • K241783 — FortiVy™ OsteoVy™ Lumbar IBF (March 18, 2025)
  • K242784 — Vy Spine™ VyLam™ Laminoplasty System (October 16, 2024)
  • K233807 — LumiVy™ Lumbar IBF System (September 24, 2024)
  • K231836 — ClariVy™ Cervical IBF System (October 30, 2023)
  • K231744 — VyLink™ Spinal Screw System (October 13, 2023)
  • K232471 — Vy Spine™ VyLam™ Laminoplasty System (October 10, 2023)
  • K232167 — VySpan™ PCT System (September 27, 2023)
  • K230414 — ClariVy™ Cervical IBF System (May 12, 2023)
  • K223513 — UniVy™ OsteoVy™-Ti Cervical IBF System (April 18, 2023)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)