Normed Titanium Osteotomy Plating System

• • Terminated Z-1524-2009 FDA Unclassified (pre-2012) ·initiated 14 Apr 2009 ·on shared 510(k) K022325

  Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K022325 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Normed Titanium Calcaneus Plating with Locking Screw System

  Class II

  FDA 510(k) K022324 Active Cleared 17 Sep 2002

• Normed Titanium Rondo Fix Fusion Plates and Screw System

  Class II

  FDA 510(k) K022323 Active Cleared 9 Sep 2002

• Normed Mini External Fixator System

  Class II

  FDA 510(k) K022230 Active Cleared 10 Sep 2002

• Normed Mandibular Fixation System

  Class II

  FDA 510(k) K010118 Active Cleared 14 Aug 2001

• Normed Bone Transport Distraction Device

  Class II

  FDA 510(k) K021341 Active Cleared 1 Aug 2002

• Normed Extremity Titanium Hand and Small Fragment System

  Class II

  FDA 510(k) K011118 Active Cleared 20 Jul 2001

See all devices from Osteomedics, Inc. →