# K263049: SABER-C System

- Pathway: 510(k) (Special)
- Applicant: Elevation Spine
- Decided: Sep 23, 2026 after 23 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: 21 generations back to K841189 (1984). 248 ancestors in all.
No later device cites it as a predicate yet.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260660: SABER-C System, Elevation Spine (2026) Summary page 5.
- K192582: NuVasive CoRoent Small Interlock System, Nu Vasive, Incorporated (2019) Summary page 6.

## Indications for use
The Elevation Spine Saber-C System is a cervical interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) and is for use in multiple contiguous spinal levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SABER-C Spacer is to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SABER-C Spacer is intended to be used with supplemental fixation, such as anterior cervical plates or posterior cervical screw fixation. The SABER-C Spacer is available in a solid titanium and a porous 3D printed titanium offering. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and screws, the plate-spacer-screw assembly can be used as a stand-alone device with the SABER-C Anterior Cervical Plate acting as the supplemental fixation. When the SABER-C Spacer is used with the SABER-C Anterior Cervical Plate and spikes, the plate-spacer-spike assembly should be used with additional supplemental fixation such as posterior cervical screw fixation. The SABER-C Anterior Cervical Plate, when used without the spacer component and with screws, is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The Anterior Cervical Plate is not to be used with spikes when used without the Spacer component.

Source page: https://510kreport.com/device/K263049
Methodology: https://510kreport.com/methodology