510(k) K963266

NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED by Intermedics Orthopedics — Product Code LPH

K963266 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED". The FDA issued a decision of Substantially Equivalent on October 15, 1996. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Intermedics Orthopedics has at least 10 other 510(k) clearances on record.