FDA product code QWK

Prosthesis, Posterior Spinal Elements

Unknown·Class 3·21 CFR ·Implantable
US regulatory classifications
US Product Code (FDA)
QWK
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.

Search keywords
About this record

Prosthesis, Posterior Spinal Elements is a medical device type in the Unknown 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.