Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Bone Cement, Posterior Screw Augmentation

FDA product code PML · 19 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3027
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-01-06 – 2026-06-15

The device is intended to augment the fixation of screws in a posterior spinal system construct.

↑