Icon Polyaxial Pedicle Screw System

• • Terminated Z-0269-2013 FDA Class II ·initiated 9 Dec 2010

  The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM.

510(k) Number

K033090 ↗

FDA Product Code

KWP

Device Class

Class II

Regulation

21 CFR Part 888.3050

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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See all devices from Alphatec Mfg., Inc. →