ClearanceBrief
510(k) K123425 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue

TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL

ApplicantSmith & Nephew, Inc., Andover MA, US
DecisionSubstantially Equivalent, Feb 20, 2013
ReceivedNov 7, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K123425

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.