Cleared Special

Vy Spine? VyLam? Laminoplasty System

K242784 · Vy Spine, LLC · Orthopedic

Oct 2024

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K242784 is an FDA 510(k) clearance for the Vy Spine? VyLam? Laminoplasty System, a Orthosis, Spine, Plate, Laminoplasty, Metal (Class II — Special Controls, product code NQW), submitted by Vy Spine, LLC (Bountiful, US). The FDA issued a Cleared decision on October 16, 2024, 30 days after receiving the submission on September 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K242784 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 16, 2024
Decision Date	October 16, 2024
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NQW — Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3050
Definition	This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.