510(k) K042783

ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM by The Anspach Effort, Inc. — Product Code HBE

K042783 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered)), a Class II device regulated under 21 CFR 882.4310. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.