Cleared Traditional

VSP PEEK Cranial Implant

K231834 · 3D Systems, Inc. · Neurology
Apr 2024
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K231834 is an FDA 510(k) clearance for the VSP PEEK Cranial Implant, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by 3D Systems, Inc. (Littleton, US). The FDA issued a Cleared decision on April 4, 2024, 287 days after receiving the submission on June 22, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K231834 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2023
Decision Date April 04, 2024
Days to Decision 287 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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