510(k) K043174

STEALTH FUSION SYSTEM, MODEL RR 1000 by R&R Medical, Inc. — Product Code KTT

K043174 is an FDA 510(k) premarket notification submitted by R&R Medical, Inc. for the device "STEALTH FUSION SYSTEM, MODEL RR 1000". The FDA issued a decision of Substantially Equivalent on Feb 7, 2005. The device falls under product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component), a Class II device regulated under 21 CFR 888.3030. R&R Medical, Inc. has 1 other 510(k) clearance on record.