510(k) K180744

Stablyx CMC Arthroplasty Implant System by Skeletal Dynamics, LLC — Product Code KYI

K180744 is an FDA 510(k) premarket notification submitted by Skeletal Dynamics, LLC for the device "Stablyx CMC Arthroplasty Implant System". The FDA issued a decision of Substantially Equivalent on April 11, 2018. The device falls under product code KYI (Prosthesis, Wrist, Carpal Trapezium), a Class II device regulated under 21 CFR 888.3770. Skeletal Dynamics, LLC has at least 10 other 510(k) clearances on record.