510(k) K183365

Libertas Acetabular Hooded Liner by Maxx Orthopedics, Inc. — Product Code LZO

K183365 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Libertas Acetabular Hooded Liner". The FDA issued a decision of Substantially Equivalent on February 22, 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. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.