# K120143: Eclipse Vertebral Spacer System-Cervical

- Pathway: 510(k) (Special)
- Applicant: Apollo Spine
- Decided: Feb 16, 2012 after 29 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: 2 generations back to P980048 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101588: Eclipse Vertebral Spacer System-Cervical, Apollo Spine, Inc. (2011) Summary page 2.

## Indications for use
The Eclipse-C Vertebral Spacer System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2 to T1. DDD is defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have completed six weeks of non-operative treatment. The Eclipse-C Vertebral Spacer System implants are to be used with autogenous bone graft. Supplemental fixation is required.

Source page: https://510kreport.com/device/K120143
Methodology: https://510kreport.com/methodology