Hallmarktm Anterior Cervical Plate System

• • Terminated Z-1653-2010 FDA Unclassified (pre-2012) ·initiated 15 Mar 2010

  The Hallmark Anterior Cervical Plate Bender may have a non conformity causing difficulty accepting 3-4 level plates or to not accept 3-4 level plates that are intended to be additionally contoured.

• • Terminated Z-0478-2008 FDA Unclassified (pre-2012) ·initiated 8 May 2006

  Incomplete Design Validation: the laser marking on the head of the screw lacked complete process qualification

510(k) Number

K050892 ↗

FDA Product Code

KWQ

Device Class

Class II

Regulation

21 CFR Part 888.3060

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Blackstone Medical, Inc. →