510(k) K172351 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Oct 30, 2017 |
| Received | Aug 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172351
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 8, 2023 | Encore Medical, LP RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component. Open, Classified |
KWS | None listed |
| Sep 19, 2023 | Encore Medical, LP DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell,
Size 6 x 108mm, REF: 533-06-108 Open, Classified |
KWS | None listed |
| Aug 31, 2020 | Encore Medical, LP AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are can Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.