FDA product code OIS

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

Orthopedic·Class 2·21 CFR 888.3045·Implantable
US regulatory classifications
US Product Code (FDA)
OIS
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 888.3045
View CFR Regulation →
Medical specialty
Orthopedic
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

Search keywords

Click to search for similar devices in our global database

About this record

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