Cleared Traditional

Flap Fixator, Burr Hole Cover

K192310 · Ossaware Biotech Co., Ltd. · Neurology
Jun 2020
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K192310 is an FDA 510(k) clearance for the Flap Fixator, Burr Hole Cover, a Cover, Burr Hole (Class II — Special Controls, product code GXR), submitted by Ossaware Biotech Co., Ltd. (Shenkang Hsiang, TW). The FDA issued a Cleared decision on June 3, 2020, 282 days after receiving the submission on August 26, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5250.

Submission Details

510(k) Number K192310 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 2019
Decision Date June 03, 2020
Days to Decision 282 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXR — Cover, Burr Hole
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5250

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