# K170550: Coveris Cervical Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine Technologies
- Decided: Jul 13, 2017 after 139 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K003155 (2001). 64 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133529: Camber Spine Coveris Cervical Cage, Camber Spine (2014) Summary page 5.
- K160528: ANATOMIC PEEK PTC Cervical Fusion System, Medtronic Sofamor Danek USA, Inc. (2016) Summary page 5.

## Most influential descendants
- K181229: TirboLOX-C Cervical IBFD (2018), 0 descendants of its own

## Indications for use
When used as a cervical intervertebral fusion device, the Coveris devices are indicated for use at one or two contiguous levels in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and with supplemental fixation (such as anterior cervical plating systems, or posterior systems) systems cleared for use in the cervical spine.

Source page: https://510kreport.com/device/K170550
Methodology: https://510kreport.com/methodology