Cleared Traditional

Longeviti ClearFit? OTS Cranial Implants

K212058 · Longeviti Neuro Solutions, LLC · Neurology
Sep 2021
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K212058 is an FDA 510(k) clearance for the Longeviti ClearFit? OTS Cranial Implants, 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 September 8, 2021, 69 days after receiving the submission on July 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K212058 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2021
Decision Date September 08, 2021
Days to Decision 69 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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