QVL — Absorbable Gel For Intraoperative Use In Spine Surgery Class II
FDA product code QVL covers "Absorbable Gel For Intraoperative Use In Spine Surgery", a Class II medical device regulated under 21 CFR 888.3047. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
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.