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510(k) K232471

Vy Spine™ VyLam™ Laminoplasty System by Vy Spine, LLC — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2023
Date Received
August 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

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  • K223513 — UniVy™ OsteoVy™-Ti Cervical IBF System (April 18, 2023)
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Other clearances for product code NQW

  • K243137 — Curiteva Porous PEEK Laminoplasty System (October 28, 2024)
  • K242784 — Vy Spine™ VyLam™ Laminoplasty System (October 16, 2024)
  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K212428 — Centerpiece Plate Fixation System (December 13, 2021)
  • K191927 — Hinged Laminoplasty System (September 20, 2019)
  • K191169 — NuVasive® Camber Laminoplasty System (July 3, 2019)
  • K181717 — Life Spine Laminoplasty System (October 12, 2018)
  • K173215 — Choice Spine Laminoplasty™ Fixation System (January 19, 2018)
  • K171413 — HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System (July 14, 2017)
  • K160114 — Xspan Laminoplasty Fixation System (March 15, 2016)