510(k) K230462

OPTIX H2 Patient Specific Instrument System by Vilex, LLC — Product Code HSN

K230462 is an FDA 510(k) premarket notification submitted by Vilex, LLC for the device "OPTIX H2 Patient Specific Instrument System". The FDA issued a decision of Substantially Equivalent on July 17, 2023. The device falls under product code HSN (Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3110. Vilex, LLC has at least 10 other 510(k) clearances on record.