510(k) K970567

SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS by Intermedics Orthopedics — Product Code KWT

K970567 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS". The FDA issued a decision of Substantially Equivalent on February 27, 1997. 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.