# DEN240038: Oxiplex®

- Pathway: De Novo (Direct)
- Applicant: Fziomed, Inc.
- Decided: Jun 17, 2025 after 330 days
- Product code: QVL (Absorbable Gel For Intraoperative Use In Spine Surgery)
- Device class: 2
- Regulation: 21 CFR 888.3047
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K253326: Oxiplex (2026), 0 descendants of its own

## Indications for use
Oxiplex® is a synthetic, absorbable gel intended as an adjunct to lumbar spinal surgery in adult patients with leg pain, back pain, and neurological symptoms undergoing discectomy to reduce leg pain and neurological symptoms.

Source page: https://510kreport.com/device/DEN240038
Methodology: https://510kreport.com/methodology