QVL

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Absorbable Gel For Intraoperative Use In Spine Surgery

Device class

Class II (moderate risk)

Regulation

21 CFR 888.3047

Medical specialty

Orthopedic

Flags

Implant

FDA 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.

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