ClearanceBrief
510(k) K200587 ยท ONN Intraoperative Orthopedic Joint Assessment Aid

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

ApplicantOrthosensor, Inc., Dania Beach FL, US
DecisionSubstantially Equivalent, Aug 25, 2020
ReceivedMar 6, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K200587

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.