# K980689: Friddle Halo System, Friddle Mri Halo System

- Pathway: 510(k) (Traditional)
- Applicant: Friddle'S Orthopedic Appliances, Inc.
- Decided: Feb 18, 1999 after 360 days
- Product code: HAX (Tong, Skull For Traction)
- Device class: 2
- Regulation: 21 CFR 882.5960
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K822885 (1982). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822885: Halo Traction Cervical Immobilization, Orthopedic Systems, Inc. (1982) Summary page 1.
- K924606: Bremer Imaging Tongs-Mri Model, Bremer Medical, Inc. (1993). Our OCR of the scanned summary read K924506, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bremer Imaging Tongs, MRI model”.
- K954069: Ace Cervical Traction Halozs, Tongs & Pins, Ace Medical Co. (1995) Summary page 1.
- K930153: System Iii Halo Ring, Jerome Medical (1993) Summary page 1.
- K834047: PMT-Halo/Orthopedic Jacket System, Progress Mankind Technology (1984) Summary page 1.

## Indications for use
This device is designed to provide traction and/or to immobilize a patient with a cervical spine injury or after surgery.

Source page: https://510kreport.com/device/K980689
Methodology: https://510kreport.com/methodology