ClearanceBrief
510(k) K161081 ยท OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

SeaSpine Shoreline ACS - Anterior Cervical Standalone System

ApplicantSeaSpine Orthopedics Corporation, Carlsbad CA, US
DecisionSubstantially Equivalent, Sep 14, 2016
ReceivedApr 18, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K161081

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.