PHOENIX 510k Summary
FDA 510(k) Summary
BioCharge 510k Summary

Download the BioCharge® 510(k) summary for regulatory reference, product documentation, and distributor support.
ROTIUM Expanded Indications 510K

Download the ROTIUM® LoPro Expanded Indications 510(k) document for regulatory reference, product documentation, and distributor support.
ROTIUM Rotator Cuff 510k Summary

Download the ROTIUM® Inlay 510(k) summary for regulatory reference, product documentation, and distributor support.