510(k) K153602 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Materialise Glenoid Positioning System
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Apr 26, 2016 |
| Received | Dec 17, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153602
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2020 | Materialise N.V. Match Point System
The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthro Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.