Cleared Traditional

Vy Spine? VyLam? Laminoplasty System

K232471 · Vy Spine, LLC · Orthopedic

Oct 2023

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K232471 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 (Tallahassee, US). The FDA issued a Cleared decision on October 10, 2023, 55 days after receiving the submission on August 16, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.

Submission Details

510(k) Number	K232471 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 16, 2023
Decision Date	October 10, 2023
Days to Decision	55 days
Submission Type	Traditional
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.