Cleared Traditional

Longeviti PMMA Static Cranial Implant

K170410 · Longeviti Neuro Solutions, LLC · Neurology
Mar 2018
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K170410 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 23, 2018, 406 days after receiving the submission on February 10, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5330.

Submission Details

510(k) Number K170410 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 2017
Decision Date March 23, 2018
Days to Decision 406 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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