510(k) K190344

DePuy Corail AMT Hip Prosthesis by Depuy(Ireland) — Product Code LZO

K190344 is an FDA 510(k) premarket notification submitted by Depuy(Ireland) for the device "DePuy Corail AMT Hip Prosthesis". The FDA issued a decision of Substantially Equivalent on November 1, 2019. 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. Depuy(Ireland) has at least 10 other 510(k) clearances on record.