510(k) K170272 ยท JEY Plate, Bone
TruMatch CMF Titanium 3D Printed Implant System
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Aug 8, 2017 |
| Received | Jan 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170272
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Terminated |
JEY | None listed |
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.