# K133529: Camber Spine Coveris Cervical Cage

- Pathway: 510(k) (Traditional)
- Applicant: Camber Spine
- Decided: Mar 20, 2014 after 125 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: 11 generations back to K003155 (2001). 57 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073440: Foundation Cage, Corelink, LLC (2008) Summary page 1.
- K120345: Honour Spacer System, Nexxt Spine, LLC (2012) Summary page 1.
- K073351: Crystal, Spinal Elements, Inc. (2008) Summary page 1.

## Most influential descendants
- K172446: SPIRA-C Open Matrix Cervical Interbody (2017), 6 descendants of its own
- K193153: SPIRA-C Integrated Fixation System (2020), 2 descendants of its own
- K222806: Kodiak C Spinal Implant System (2022), 1 descendant of its own
- K170550: Coveris Cervical Cage System (2017), 1 descendant of its own
- K253894: BMD Titanium Spinal Fusion System (2026), 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 level in the cervical spine, from C0-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (ODD) with up to Grade 1 spondylolisthesis. ODD 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 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/K133529
Methodology: https://510kreport.com/methodology