Cleared Traditional

Longeviti ClearFit Cranial Implant

K191210 · Longeviti Neuro Solutions, LLC · Neurology
Jan 2020
Decision
248d
Days
Class 2
Risk

About This 510(k) Submission

K191210 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 January 9, 2020, 248 days after receiving the submission on May 6, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K191210 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2019
Decision Date January 09, 2020
Days to Decision 248 days
Submission Type Traditional
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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