ClearanceBrief
510(k) K103012 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS

ApplicantExactech, Inc., Gainesville FL, US
DecisionSubstantially Equivalent, Nov 10, 2010
ReceivedOct 12, 2010
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K103012

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.