Cleared Special

Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade

K151387 · Stryker · Neurology
Jun 2015
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K151387 is an FDA 510(k) clearance for the Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade, a Fastener, Plate, Cranioplasty (Class II — Special Controls, product code HBW), submitted by Stryker (Portage, US). The FDA issued a Cleared decision on June 24, 2015, 29 days after receiving the submission on May 26, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5360.

Submission Details

510(k) Number K151387 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2015
Decision Date June 24, 2015
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

Similar Devices — HBW Fastener, Plate, Cranioplasty

Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251472 · Inion OY · Jul 2025
Stryker Resorbable Fixation System
K231208 · Stryker Leibinger GmbH & Co KG · Aug 2023
Stryker Universal Neuro III System AXS Screw
K171152 · Stryker · May 2017
DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
K141385 · Depuy Synthes Companies of Johnson & Johnson · Mar 2015
MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
K101835 · Porex Surgical, Inc. · Dec 2010
MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM
K001353 · Biomedical Ent., Inc. · Mar 2001