Cleared Traditional

Longeviti PorousFit implant

K211514 · Longeviti Neuro Solutions, LLC · General & Plastic Surgery

Jul 2021

Decision

59d

Days

Class 2

Risk

About This 510(k) Submission

K211514 is an FDA 510(k) clearance for the Longeviti PorousFit implant, a Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction (Class II — Special Controls, product code KKY), submitted by Longeviti Neuro Solutions, LLC (Hunt Valley, US). The FDA issued a Cleared decision on July 15, 2021, 59 days after receiving the submission on May 17, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3500.

Submission Details

510(k) Number	K211514 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 2021
Decision Date	July 15, 2021
Days to Decision	59 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	KKY — Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.3500