510(k) K132250

INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM by Integra LifeSciences Corporation — Product Code JWJ

K132250 is an FDA 510(k) premarket notification submitted by Integra LifeSciences Corporation for the device "INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 2014. 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. Integra LifeSciences Corporation has at least 10 other 510(k) clearances on record.