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.

Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

FDA product code OIS · 1 cleared devices

Class 2 Orthopedic
Regulation
21 CFR 888.3045
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2008-07-02 – 2008-07-02

To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.

↑