510(k) K052058

MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL by Fournitures Hospitalieres Industrie — Product Code HSB

K052058 is an FDA 510(k) premarket notification submitted by Fournitures Hospitalieres Industrie for the device "MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL". The FDA issued a decision of Substantially Equivalent on Aug 22, 2005. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Fournitures Hospitalieres Industrie has 23 other 510(k) clearances on record.