510(k) K962238

SELECT SHOULDER KEELED ALL-POLY GLENOIDS by Intermedics Orthopedics — Product Code KWT

K962238 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "SELECT SHOULDER KEELED ALL-POLY GLENOIDS". The FDA issued a decision of SN on August 9, 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.