# K122085: Stingray Cervical Cage

- Pathway: 510(k) (Abbreviated)
- Applicant: Omni Surgical, LP Dba Spine360
- Decided: Oct 17, 2012 after 93 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 K841189 (1984). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082801: Phantom Plus Cage System, Us Spine (2008) Summary page 2.
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.

## Indications for use
The Spine3EO Stingray Cervical Interbody Fusion System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. OIDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Spine 360 Cervical Interbody Fusion System implants are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to Ti disc levels using autograft bone. The Spine 360 Cervical Interbody Fusion System implants are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

Source page: https://510kreport.com/device/K122085
Methodology: https://510kreport.com/methodology