510(k) K010442

KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652 by Heinz Kurz — Product Code ETB

K010442 is an FDA 510(k) premarket notification submitted by Heinz Kurz for the device "KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652". The FDA issued a decision of Substantially Equivalent on March 8, 2001. 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.