510(k) K080074

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX by Ace Surgical Supply Co., Inc. — Product Code DZE

K080074 is an FDA 510(k) premarket notification submitted by Ace Surgical Supply Co., Inc. for the device "ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX". The FDA issued a decision of Substantially Equivalent on February 14, 2008. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Ace Surgical Supply Co., Inc. has at least 10 other 510(k) clearances on record.