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FDA product code QVL

Absorbable Gel For Intraoperative Use In Spine Surgery

OrthopedicClass 221 CFR 888.3047Implantable
US regulatory classifications
US Product Code (FDA)
QVL
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3047
Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Absorbable Gel For Intraoperative Use In Spine Surgery is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.