Mozaik Bone Regeneration Matrix - Putty

• • Terminated Z-1796-2012 FDA Class II ·initiated 11 Oct 2011

  The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

• • Terminated Z-0986-2012 FDA Unclassified (pre-2012) ·initiated 7 Oct 2011

  Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.

• • Terminated Z-1034-2009 FDA Unclassified (pre-2012) ·initiated 16 Jan 2009

  Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

510(k) Number

K062353 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• DuraGen® Suturable

  Class III

  CE/MDD

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  Class I

  CE/MDR

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  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 →