Cleared Special

Longeviti ClearFit OTS Cranial Implant

K231920 · Longeviti Neuro Solutions, LLC · Neurology
Nov 2023
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K231920 is an FDA 510(k) clearance for the Longeviti ClearFit OTS 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 November 9, 2023, 133 days after receiving the submission on June 29, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K231920 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 2023
Decision Date November 09, 2023
Days to Decision 133 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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