510(k) K172467

OMNI ARC Anteverted Neck Hip Stem by Omnilife Science — Product Code LZO

K172467 is an FDA 510(k) premarket notification submitted by Omnilife Science for the device "OMNI ARC Anteverted Neck Hip Stem". The FDA issued a decision of Substantially Equivalent on December 21, 2017. 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. Omnilife Science has at least 6 other 510(k) clearances on record.