510(k) DEN240038

Oxiplex® by Fziomed, Inc. — Product Code QVL

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: June 17, 2025
Date Received: July 22, 2024
Clearance Type: Direct
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Absorbable Gel For Intraoperative Use In Spine Surgery
Device Class: Class II
Regulation Number: 888.3047
Review Panel: OR
Submission Type

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.