510(k) K961727

NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM by Intermedics Orthopedics — Product Code LZO

K961727 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM". The FDA issued a decision of Substantially Equivalent on July 19, 1996. 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. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.