QVL · Class II · 21 CFR 888.3047

FDA Product Code QVL: Absorbable Gel For Intraoperative Use In Spine Surgery

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.

Leading manufacturers include Fziomed, Inc..

2
Total
1
Cleared
272d
Avg days
2025
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Absorbable Gel For Intraoperative Use In Spine Surgery Devices (Product Code QVL)

2 devices
1–2 of 2
Cleared May 01, 2026
Oxiplex
K253326
Fziomed, Inc.
Orthopedic · 213d
Not Cleared Jun 17, 2025
Oxiplex®
DEN240038
Fziomed, Inc.
Orthopedic · 330d

About Product Code QVL - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QVL since 2025, with 1 receiving FDA clearance (average review time: 272 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

QVL devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →