510(k) K041651

STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM by Stryker Leibinger — Product Code DZE

K041651 is an FDA 510(k) premarket notification submitted by Stryker Leibinger for the device "STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 2004. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Stryker Leibinger has at least 10 other 510(k) clearances on record.