ClearanceBrief
510(k) K080402 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38

ApplicantEncore Medical L.P., Austin TX, US
DecisionSubstantially Equivalent, Mar 28, 2008
ReceivedFeb 14, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K080402

DateFirm and productCodeLinked 510(k)
Dec 22, 2010Encore Medical, Lp
Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
Terminated		 KWSNone listed
Dec 22, 2010Encore Medical, Lp
Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical
Terminated		 KWSNone listed
Dec 22, 2010Encore Medical, Lp
Turon Shoulder System Instrumentation, Turon Trial Pegged Glenoid, DJO Surgical
Terminated		 KWSNone listed
Dec 22, 2010Encore Medical, Lp
Turon Shoulder System Instrumentation, Turon Pegged Glenoid Drill Guide, REF 804-25-024, DJO Surgical
Terminated		 KWSNone listed

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