Vy Spine VyLam Laminoplasty System— 510(k) K232471

Name: FDA 510(k) clearance K232471
Creator: U.S. Food and Drug Administration
Published: 2023-10-10

Substantially Equivalent

Vy Spine, LLC

FDA 510(k) clearance K232471 for Vy Spine VyLam Laminoplasty System, Substantially Equivalent on 2023-10-10. Applicant: Vy Spine, LLC. Device class: 2.

Clearance details

Applicant: Vy Spine, LLC
Product code: Code NQW
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2023-08-16
Decision date: 2023-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tallahassee, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.