Cleared Special

Longeviti PMMA Static Cranial Implant

K210616 · Longeviti Neuro Solutions, LLC · Neurology
Mar 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K210616 is an FDA 510(k) clearance for the Longeviti PMMA Static 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 March 31, 2021, 30 days after receiving the submission on March 1, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K210616 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2021
Decision Date March 31, 2021
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement

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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