510(k) K962244

SELECT SHOULDER PEGGED ALL-POLY GLENOID by Intermedics Orthopedics — Product Code KWT

K962244 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "SELECT SHOULDER PEGGED ALL-POLY GLENOID". 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.