QVL — Absorbable Gel For Intraoperative Use In Spine Surgery Class II
Classification Details
- Product Code
- QVL
- Device Class
- Class II
- Regulation Number
- 888.3047
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
This device is an absorbable gel implant for intraoperative use in spinal procedures that is applied to nerve roots after hemostasis has been achieved and prior to closure. The device is intended as an adjunct to the surgical procedure to reduce pain and neurological symptoms.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240038 | fziomed | Oxiplex® | June 17, 2025 |