Intervertebral Body Graft Containment Device

OQB · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3085

Classification

FDA Product Code: OQB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3085
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 2

Source

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