Olive K-Wires

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K903105 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

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. →

• What are Olive K-Wires used for?

  Olive K-Wires are invasive traction components specifically designed for orthopedic applications. They are utilized by clinicians to provide necessary skeletal traction and stabilization for patients.

• What is the regulatory status of this device?

  Olive K-Wires are classified as a class 2 medical device under regulation number 888.3040. The device has received FDA 510(k) clearance, which indicates that it has been found substantially equivalent to a legally marketed predicate device.

• Which medical specialty is this device associated with?

  This device is categorized under the orthopedic medical specialty. It is reviewed by the orthopedic advisory committee, reflecting its intended use in skeletal stabilization and traction procedures.