# K983282: Omi Occipital Cervical Loop, Model A1089

- Pathway: 510(k) (Traditional)
- Applicant: Ohio Medical Instrument Co., Inc.
- Decided: Nov 19, 1998 after 62 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K853033 (1985). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965221: Ransford Cervical Fixation System, Surgicraft, Ltd. (1997) Summary page 3.

## Indications for use
The OMI® Occipital Cervical Loop is intended to be used to assist stabilization and fusion of the cervical spine and cervical occipital junction. 1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disk as confirmed by patient history and radiological studies). Spondylolisthesis of the cervical vertebrae. Spinal stenosis of the cervical vertebrae. Atlanto/axial fracture with instability. Cervical-occipital dislocation. Revision of previous cervical fusion surgery. Tumors.

Source page: https://510kreport.com/device/K983282
Methodology: https://510kreport.com/methodology