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Posterior Metal/Polymer Spinal System, Fusion

FDA product code NQP · 21 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3070
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2004-03-05 – 2021-01-15

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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