ClearanceBrief
510(k) K013764 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

IMMIX BONE GRAFT EXTENDER

ApplicantOsteogenics Biomedical, Inc., Fort Worth TX, US
DecisionSubstantially Equivalent, May 16, 2002
ReceivedNov 13, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K013764

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.