Cleared Special

Longeviti ClearFit Cranial Implant

K203349 · Longeviti Neuro Solutions, LLC · Neurology
Dec 2020
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K203349 is an FDA 510(k) clearance for the Longeviti ClearFit Cranial Implant, a Plate, Cranioplasty, Preformed, Non-alterable (Class II — Special Controls, product code GXN), submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on December 16, 2020, 33 days after receiving the submission on November 13, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K203349 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 2020
Decision Date December 16, 2020
Days to Decision 33 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXN — Plate, Cranioplasty, Preformed, Non-alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5330

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