510(k) K223828

BENCOX Delta Option Heads by Corentec Co., Ltd. — Product Code LZO

K223828 is an FDA 510(k) premarket notification submitted by Corentec Co., Ltd. for the device "BENCOX Delta Option Heads". The FDA issued a decision of Substantially Equivalent on March 16, 2023. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Corentec Co., Ltd. has at least 10 other 510(k) clearances on record.