Cleared Special

Stryker Universal Neuro III System AXS Screw

K171152 · Stryker · Neurology
May 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K171152 is an FDA 510(k) clearance for the Stryker Universal Neuro III System AXS Screw, a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on May 19, 2017, 29 days after receiving the submission on April 20, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.

Submission Details

510(k) Number K171152 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2017
Decision Date May 19, 2017
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBW — Fastener, Plate, Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5360

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