Normandy VBR System— 510(k) K191423

Name: FDA 510(k) clearance K191423
Creator: U.S. Food and Drug Administration
Published: 2019-08-06

Substantially Equivalent

Zavation Medical Products, LLC

FDA 510(k) clearance K191423 for Normandy VBR System, Substantially Equivalent on 2019-08-06. Applicant: Zavation Medical Products, LLC. Device class: 2.

Clearance details

Applicant: Zavation Medical Products, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2019-05-29
Decision date: 2019-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flowood, MS, US

Download summary PDF View on FDA.gov ↗

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