510(k) K071147

NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM by Nexa Orthopedics, Inc. — Product Code KWT

K071147 is an FDA 510(k) premarket notification submitted by Nexa Orthopedics, Inc. for the device "NEXA ORTHOPEDICS TOTAL SHOULDER SYSTEM". The FDA issued a decision of Substantially Equivalent on July 20, 2007. The device falls under product code KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented), a Class II device regulated under 21 CFR 888.3650. Nexa Orthopedics, Inc. has at least 10 other 510(k) clearances on record.