ClearanceBrief
510(k) K162024 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

AltiVate Anatomic Shoulder System

ApplicantEncore Medical L.P., Austin TX, US
DecisionSubstantially Equivalent, Nov 21, 2016
ReceivedJul 22, 2016
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K162024

DateFirm and productCodeLinked 510(k)
Jun 28, 2021Encore Medical, LP
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000
Open, Classified		 KWSNone listed
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed		 KWSNone listed
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 42mm, REF 804-07-420 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed		 KWSNone listed
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 46mm, REF 804-07-460 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed		 KWSNone listed
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 50mm, REF 804-07-500 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulde
Completed		 KWSNone listed
Jan 29, 2018Encore Medical, Lp
Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 54mm, REF 804-07-540 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoul
Completed		 KWSNone listed

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