Posterior Metal/Polymer Spinal System, Fusion

NQP · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3070

Classification

FDA Product Code: NQP
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3070
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 a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Market data

Cleared 510(k) submissions: 22
Registered establishments: 43

Source

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