Dorsal Nail Plate, Anatomical

• • Terminated Z-2212-2014 FDA Class II ·initiated 23 Jun 2014

  The firm received complaints indicating that the drill guide becomes stuck in the jig. The drill guide can be placed in the jig about halfway before it becomes stuck.

• 4 recalls, same reason

  • Terminated Z-0982-2009 FDA Unclassified (pre-2012) ·initiated 23 Dec 2008
  • Terminated Z-0984-2009 FDA Unclassified (pre-2012) ·initiated 23 Dec 2008
  • Terminated Z-0983-2009 FDA Unclassified (pre-2012) ·initiated 23 Dec 2008
  • Terminated Z-0981-2009 FDA Unclassified (pre-2012) ·initiated 23 Dec 2008

  The DNP nail plate may not attach to the alignment guide (jig) instrument, making it difficult to insert the nail plate into position or to drill needed holes accurately.

510(k) Number

K052248 ↗

FDA Product Code

HRS

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Fragment Plate System, Screws, Pins and K-Wires

  Class II

  FDA 510(k) K041081 Active Cleared 1 Jul 2004

• Shoulder Fixation System

  Class II

  FDA 510(k) K042059 Active Cleared 30 Sep 2004

• Small Bone Fixation System

  Class II

  FDA 510(k) K033406 Active Cleared 15 Jan 2004

• Modification to Small Bone Fixation System

  Class II

  FDA 510(k) K041157 Active Cleared 30 Jul 2004

• Distal Radius Fracture Repair System

  Class II

  FDA 510(k) K032705 Active Cleared 1 Oct 2003

• Hand Innovations, Inc. Distal Radius Fracture Repair System

  Class II

  FDA 510(k) K030198 Active Cleared 1 Apr 2003

See all devices from Hand Innovations, LLC →