Cleared Special

K182425 - Universal Mesh - Sterile
(FDA 510(k) Clearance)

K182425 · Stryker Leibinger GmbH & Co KG · Neurology

Nov 2018

Decision

61d

Days

Class 2

Risk

K182425 is an FDA 510(k) clearance for the Universal Mesh - Sterile, a Plate, Cranioplasty, Preformed, Alterable (Class II — Special Controls, product code GWO), submitted by Stryker Leibinger GmbH & Co KG (Freiburg, DE). The FDA issued a Cleared decision on November 6, 2018, 61 days after receiving the submission on September 6, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5320.

Submission Details

510(k) Number	K182425 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 2018
Decision Date	November 06, 2018
Days to Decision	61 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF