De Novo DEN240038

Device: Oxiplex®
Contact: lisa gawehn
De Novo number: DEN240038
Product code: QVL
Regulation: 888.3047
Classification name: absorbable gel for intraoperative use in spine surgery
Decision: granted (DENG)
Decision date: 2025-06-17
Date received: 2024-07-22
Classification advisory: Orthopedic
Review advisory: Orthopedic
Type: Direct

Current FDA Classification#

Product code: QVL
Device name: Absorbable Gel For Intraoperative Use In Spine Surgery
Medical specialty: Orthopedic
Device class: 2
Regulation: 888.3047
Implant: Y
Life sustain/support: N