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Absorbable Gel For Intraoperative Use In Spine Surgery

FDA product code QVL · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3047
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-05-01 – 2026-05-01

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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