510(k) K961799

NATURAL HIP SYSTEM - DRG HIP STEM by Intermedics Orthopedics — Product Code JDI

K961799 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "NATURAL HIP SYSTEM - DRG HIP STEM". The FDA issued a decision of Substantially Equivalent on July 15, 1996. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.