Mayfield Skull Clamp

• • Terminated Z-0210-2014 FDA Class II ·initiated 29 Aug 2013

  An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.

• • Terminated Z-0559-2013 FDA Class II ·initiated 5 Nov 2012

  An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d

510(k) Number

K120633 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• DuraGen® Suturable

  Class III

  CE/MDD

• Mayfield®

  Class I

  CE/MDR

• Integra Flow Regulating Valve Systems Osv II Models and Integra Flow Regulating Valve Low Flow Models

  Class II

  FDA 510(k) K140722 Active Cleared 6 Jan 2015

• INTEGRA Wound Matrix (Macro-Channels)

  Unclassified

  FDA 510(k) K210128 Active Cleared 8 Oct 2021

• Mayfield Radiolucent Disposable Skull Pins

  Class II

  FDA 510(k) K071458 Active Cleared 13 Jun 2007

• Licox Pmo Brain Monitoring System

  Class II

  FDA 510(k) K040235 Active Cleared 20 Apr 2004

See all devices from Integra Lifesciences Corporation →