510(k) K181026 · HSB Rod, Fixation, Intramedullary And Accessories
OsteoBridge IDSF System
| Applicant | Merete GmbH, Berlin, DE |
| Decision | Substantially Equivalent, Oct 17, 2018 |
| Received | Apr 18, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur) Terminated |
HSB | None listed |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia) Terminated |
HSB | None listed |
| Sep 18, 2020 | Merete Medical GmbH OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus) Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.