FDA product code NQP

Posterior Metal/Polymer Spinal System, Fusion

Orthopedic·Class 2·21 CFR 888.3070·Implantable
US regulatory classifications
US Product Code (FDA)
NQP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3070
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Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Posterior Metal/Polymer Spinal System, Fusion is a medical device type in the Orthopedic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.