510(k) K990923

TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010 by Heinz Kurz — Product Code ETB

K990923 is an FDA 510(k) premarket notification submitted by Heinz Kurz for the device "TUBINGEN TITANIUM PROSTHESIS (TTP) VARIO, MODELS AERIAL 1004 010 & BELL 1002 010". The FDA issued a decision of Substantially Equivalent on March 31, 1999. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Heinz Kurz has at least 4 other 510(k) clearances on record.