Fortex Pedicle Screw System

• • Terminated Z-1884-2017 FDA Class II ·initiated 12 Apr 2017

  The material type on the label may incorrectly state Ti6Al-4V ELI. The rods are composed of Cobalt Chromium.

• • Terminated Z-1823-2015 FDA Class II ·initiated 7 Apr 2015

  The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length.

• • Terminated Z-1512-2015 FDA Class II ·initiated 11 Mar 2015

  One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x 55mm instead of 5.5 x 55mm as described on the product label.

510(k) Number

K120832 ↗

FDA Product Code

MNH

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K112592 Active Cleared 5 Dec 2011

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  FDA 510(k) K152132 Active Cleared 25 Sep 2015

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  FDA 510(k) K160114 Active Cleared 15 Mar 2016

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  Class II

  FDA 510(k) K170530 Active Cleared 22 Mar 2017

See all devices from X-Spine Systems, Inc. →