ClearanceBrief
510(k) K050118 ยท HSB Rod, Fixation, Intramedullary And Accessories

EBI TROCHANTERIC NAIL SYSTEM

ApplicantEbi, L.P., Parsippany NJ, US
DecisionSubstantially Equivalent, Feb 16, 2005
ReceivedJan 18, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K050118

DateFirm and productCodeLinked 510(k)
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Rod, fixation, intramedullary and accessories.
Terminated
HSBNone listed
Apr 30, 2012Biomet, Inc.
REF 28234 Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System, Rx Sterile Biomet Trauma Persippany, NJ Rod, Fixation, Intramedullary and Accessories Product Usage: An intramedullary fixa
Terminated
HSBNone listed
Oct 7, 2005EBI, L.P.
EBI Trochanteric 11mm Long Nail.
Terminated
JDSNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.