510(k) K070170

DALL-MILES SYSTEM by Stryker Orthopaedics — Product Code HRS

K070170 is an FDA 510(k) premarket notification submitted by Stryker Orthopaedics for the device "DALL-MILES SYSTEM". The FDA issued a decision of Substantially Equivalent on March 2, 2007. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Stryker Orthopaedics has at least 10 other 510(k) clearances on record.