Cleared Traditional

Vy Spine? VyWasher? Buttress System

K213219 · Vy Spine, LLC · Orthopedic
Dec 2021
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K213219 is an FDA 510(k) clearance for the Vy Spine? VyWasher? Buttress System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Vy Spine, LLC (Tallahassee, US). The FDA issued a Cleared decision on December 23, 2021, 85 days after receiving the submission on September 29, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K213219 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2021
Decision Date December 23, 2021
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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