510(k) K023667

RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE by Plus Orthopedics — Product Code KRO

K023667 is an FDA 510(k) premarket notification submitted by Plus Orthopedics for the device "RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE". The FDA issued a decision of Substantially Equivalent on December 24, 2002. The device falls under product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3510. Plus Orthopedics has at least 10 other 510(k) clearances on record.