# K101588: Eclipse Vertebral Spacer System-Cervical

- Pathway: 510(k) (Traditional)
- Applicant: Apollo Spine, Inc.
- Decided: Jan 7, 2011 after 214 days
- Product code: OVE (Intervertebral Fusion Device With Integrated Fixation, 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: 1 generation back to P980048 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P980048: Bak/Cervical (Bak/C) Interbody Fusion System, Sulzer Spine-Tech (2001) Summary page 1.
- (no number) LDR Spine Cervical Interbody Fusion System, ROI-C: named in the summary without a submission number
- (no number) SpineCraft ORIO-C Intervertebral Body Fusion Cervical Cage: named in the summary without a submission number

## Most influential descendants
- K120143: Eclipse Vertebral Spacer System-Cervical (2012), 0 descendants of its own

## Indications for use
The Eclipse Vertebral Spacer System-Cervical 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 Vertebral Spacer System-Cervical implants are to be used with autogenous bone graft. Supplemental fixation is required.

Source page: https://510kreport.com/device/K101588
Methodology: https://510kreport.com/methodology