Intergro Dbm

• • Terminated Z-0618-2008 FDA Unclassified (pre-2012) ·initiated 15 Oct 2007

  Unapproved Testing:Interpore Cross International was recently informed that one of its human tissue suppliers, LifeLink Tissue Bank ("LifeLink"), utilized unapproved diagnostic testing (HBsAg & HBc) on certain lots of distributed donor tissue instead of the FDA approved screening test. As a result, Interpore Cross International has initiated a recall on specific lots of products containing human

510(k) Number

K031399 ↗

FDA Product Code

MQV

Device Class

Class II

Regulation

21 CFR Part 888.3045

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Altius Oct System

  Class II

  FDA 510(k) K033961 Active Cleared 14 Apr 2004

• Modification to Synergy Spinal System

  Class II

  FDA 510(k) K010515 Active Cleared 22 Mar 2001

• Pro Osteon Implant 500R Resorbable Bone Graft Substitute

  Class II

  FDA 510(k) K990131 Active Cleared 2 Mar 1999

• Ti Fenestrated Plate

  Class II

  FDA 510(k) K031772 Active Cleared 5 Sep 2003

• Telescopic Plate Spacer Thoracolumbar (Tps-Tl) Spinal System, Models 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189

  Class II

  FDA 510(k) K020204 Active Cleared 21 Feb 2002

• Synergy Adjustable Length Rod

  Class II

  FDA 510(k) K990057 Active Cleared 28 Jun 1999

See all devices from Interpore Cross Intl. →