Cleared Traditional

Biopor Porous Polyethylene Implants

K161446 · Ceremed , Inc. · Neurology
Sep 2016
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K161446 is an FDA 510(k) clearance for the Biopor Porous Polyethylene Implants, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Ceremed , Inc. (Los Angeles, US). The FDA issued a Cleared decision on September 27, 2016, 125 days after receiving the submission on May 25, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number K161446 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2016
Decision Date September 27, 2016
Days to Decision 125 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWO — Plate, Cranioplasty, Preformed, Alterable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5320

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