DEN240038
- 510(k) number
- DEN240038
- Device name
- Oxiplex®
- Applicant
- Fziomed, Inc. CA · US
- Product code
- QVL — Absorbable Gel For Intraoperative Use In Spine Surge
- Decision date
- 2025-06-17
- Date received
- 2024-07-22
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Orthopedic
Official FDA record: DEN240038
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.