# K070994: Eagle + Anterior Cervical Plate System

- Pathway: 510(k) (Special)
- Applicant: Depuy Spine, Inc.
- Decided: May 9, 2007 after 30 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: 2 generations back to K971730 (1997). 2 ancestors in all.
204 later devices descend from it; 4 cite it directly.
0 of 207 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040197: Eagle Anterior Cervial Plate System, Depuyacromed (2004) Summary page 1.

## Most influential descendants
- K072546: Swift Plus Anterior Cervical Plate System (2007), 195 descendants of its own
- K080646: C-Tek Maxan Anterior Cervical Plate System (2008), 193 descendants of its own
- K133475: Struxxure Anterior Cervical Plate and Screws (2013), 132 descendants of its own
- K141376: Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws (2014), 106 descendants of its own
- K181435: ATEC Cervical Spacer System (2018), 100 descendants of its own

## Indications for use
The EAGLETM + Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1. Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

Source page: https://510kreport.com/device/K070994
Methodology: https://510kreport.com/methodology