510(k) K962315

SELECT SHOULDER COCR HUMERAL STEM COMPONENT by Intermedics Orthopedics — Product Code KWT

K962315 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "SELECT SHOULDER COCR HUMERAL STEM COMPONENT". The FDA issued a decision of Substantially Equivalent on September 3, 1996. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.