K253326
- 510(k) number
- K253326
- Device name
- Oxiplex
- Applicant
- Fziomed, Inc. CA · US
- Product code
- QVL — Absorbable Gel For Intraoperative Use In Spine Surge
- Decision date
- 2026-05-01
- Date received
- 2025-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K253326.pdf
Official FDA record: K253326
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.