510(k) K964350

MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA by Intermedics Orthopedics — Product Code JDI

K964350 is an FDA 510(k) premarket notification submitted by Intermedics Orthopedics for the device "MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA". The FDA issued a decision of Substantially Equivalent on January 16, 1997. 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.