510(k) K092548

EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS by Extremity Medical, LLC — Product Code KYI

K092548 is an FDA 510(k) premarket notification submitted by Extremity Medical, LLC for the device "EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 15, 2009. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Extremity Medical, LLC has at least 10 other 510(k) clearances on record.