Danek Wrist Fixator

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K891066 ↗

FDA Product Code

KTT

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Modification of Tsrh Spinal System

  Class II

  FDA 510(k) K984522 Active Cleared 6 Jan 1999

• Overhead Arm Slings

  Class I

  FDA 510(k) K823811 Active Cleared 14 Jan 1983

• Cd Horizon Spinal System

  Class II

  FDA 510(k) K993810 Active Cleared 3 Feb 2000

• Danek Precision Rod Set

  Class II

  FDA 510(k) K896254 Active Cleared 14 Jun 1990

• Spine Fixation

  Class II

  FDA 510(k) K943827 Active Cleared 14 Feb 1996

• Modification of the Zplate-Atl Anterior Fixation System

  Class II

  FDA 510(k) K990603 Active Cleared 10 Mar 1999

See all devices from Danek Medical, Inc. →