510(k) K990094

KMI WRIST FUSION SYSTEM by Kinetikos Medical, Inc. — Product Code HRS

K990094 is an FDA 510(k) premarket notification submitted by Kinetikos Medical, Inc. for the device "KMI WRIST FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on February 18, 1999. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Kinetikos Medical, Inc. has at least 10 other 510(k) clearances on record.