# K042073: Olsen Medical Anterior Cervical Vertebrae Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Olsen Medical
- Decided: Feb 7, 2005 after 189 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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 K031276 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031276: Synthes Anterior Cervical Locking Plate (Aclp) System, Synthes (Usa) (2003) Summary page 1.

## Indications for use
The Olsen Medical Dynamic and Semiconstrained Plates are intended for anterior screw fixation of the cervical spine (C2 to C7) for the following indications: degenerative disc disease (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis and tumors (primary and metastatic), deformities or curvatures (i.e., scoliosis, kyphosis, and lordosis), pseudoarthrosis and failed previous fusions.

Source page: https://510kreport.com/device/K042073
Methodology: https://510kreport.com/methodology