# K163246: Leva Anterior Expandable Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Spine Wave, Inc.
- Decided: Apr 6, 2017 after 139 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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 P950019 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141980: Leva (TM) Spacer System, Spine Wave, Inc. (2015) Summary page 4.

## Indications for use
The Leva® Anterior Expandable Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Leva® Anterior Expandable Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervettebral body fusion device.

Source page: https://510kreport.com/device/K163246
Methodology: https://510kreport.com/methodology