ClearanceBrief
510(k) K113320 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12

ApplicantExactech, Inc., Gainesville FL, US
DecisionSubstantially Equivalent, Mar 16, 2012
ReceivedNov 10, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K113320

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.