510(k) K253326
- Device
- Oxiplex
- Applicant
- Fziomed, Inc.
- 510(k) number
- K253326
- Product code
- QVL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-01
- Date received
- 2025-09-30
- Regulation
- 888.3047
- Classification name
- Absorbable Gel For Intraoperative Use In Spine Surgery
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Paul Mraz
- Address
- 231 Bonetti Dr. San Luis Obispo CA US 93401 93401
FDA Registration Numbers#
- 2031637
Source Documents#
Other 510(k) Records For Product Code QVL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240038 | Oxiplex® | Fziomed, Inc. | 2025-06-17 |