Absorbable Gel For Intraoperative Use In Spine Surgery
The Absorbable Gel for Intraoperative Use in Spine Surgery is a resorbable implant applied to nerve roots during spinal surgery after hemostasis has been achieved and prior to wound closure, intended to reduce postoperative pain and neurological symptoms as an adjunct to the surgical procedure. The gel resorbs over time and does not require a separate removal procedure. Classified as FDA Class 2 under regulation 888.3047, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. It is not life-sustaining.
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Basic Information
- Product Code
- QVL
- Device Class
- FDA class 2
- Regulation Number
- 888.3047
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.