510(k) K233674

Freedom Wrist Arthroplasty System by Ascension Orthopedics, Inc. — Product Code JWJ

K233674 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "Freedom Wrist Arthroplasty System". The FDA issued a decision of Substantially Equivalent on May 30, 2024. The device falls under product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.