510(k) K182705

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups by B-One Ortho, Corp. — Product Code LZO

K182705 is an FDA 510(k) premarket notification submitted by B-One Ortho, Corp. for the device "Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups". The FDA issued a decision of Substantially Equivalent on February 14, 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. B-One Ortho, Corp. has at least 10 other 510(k) clearances on record.