510(k) K200587

VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder by Orthosensor, Inc. — Product Code ONN

K200587 is an FDA 510(k) premarket notification submitted by Orthosensor, Inc. for the device "VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder". The FDA issued a decision of Substantially Equivalent on August 25, 2020. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Orthosensor, Inc. has at least 7 other 510(k) clearances on record.