510(k) K002484

EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL by Electro Medical Systems SA — Product Code JDX

K002484 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL". The FDA issued a decision of Substantially Equivalent on October 4, 2000. The device falls under product code JDX (Instrument, Surgical, Sonic And Accessory/Attachment), a Class II device regulated under 21 CFR 888.4580. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.