DeviceClearance

Product code QVL— Orthopedic

Oxiplex

Classification name
Absorbable Gel For Intraoperative Use In Spine Surgery
Device class
Class 2
Regulation
21 CFR 888.3047
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QVL under 21 CFR 888.3047, via openFDA

Market context for product code QVL

FDA has cleared 2 devices under product code QVL between 2025 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QVL

Recent clearances under product code QVL

Data sourced from openFDA. This site is unofficial and independent of the FDA.