Absorbable Gel For Intraoperative Use In Spine Surgery

QVL · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3047

Classification

FDA Product Code: QVL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3047
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown