System III Halo Ring

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K930153 ↗

FDA Product Code

JEC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Warm'n Form Sports Supports

  Class I

  FDA 510(k) K821582 Active Cleared 10 Jun 1982

• Resolve Open Back Halo Rings

  Class II

  FDA 510(k) K051918 Active Cleared 17 Aug 2005

• JMS Cervical Traction Device/Halo Device

  Class II

  FDA 510(k) K882877 Active Cleared 30 Sep 1988

• Torquedriver Wrench

  Class I

  FDA 510(k) K870053 Active Cleared 11 Mar 1987

• Jms Halo Application Tray

  Class I

  FDA 510(k) K864969 Active Cleared 18 Feb 1987

• Cervical Brace

  Class II

  FDA 510(k) K822780 Active Cleared 6 Oct 1982

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• What is the System III Halo Ring used for?

  The System III Halo Ring is used to hold the skull firmly in place relative to the torso when part of a halo traction system, thereby stabilizing the cervical vertebrae in orthopedic applications.

• Is the System III Halo Ring sterile or non-sterile, and is it intended for single-use or reuse?

  The System III Halo Ring is supplied non-sterile and is intended for reusable use, meaning it must be cleaned and sterilized by the user before each application according to established protocols.

• What regulatory pathway was used for the System III Halo Ring, and what is its classification?

  The System III Halo Ring received FDA 510(k) clearance (K930153) on August 6, 1993, as substantially equivalent to a predicate device, and is classified as a Class II medical device under regulation 888.3040 with product code JEC.