510(k) K182201 · HRS Plate, Fixation, Bone
Stratum Foot Plating System
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 16, 2018 |
| Received | Aug 14, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182201
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2019 | Nextremity Solutions Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation. Terminated |
HRS | None listed |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x46mm ST
Part Number: STRM-MDS-3546ST Terminated |
HWC | None listed |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x48mm ST
Part Number: STRM-MDS-3548ST Terminated |
HWC | None listed |
| Nov 11, 2019 | Nextremity Solutions Stratum MDS Screw 3.5x50mm ST
Part Number: STRM-MDS-3550ST Terminated |
HWC | None listed |
| Oct 9, 2019 | Nextremity Solutions Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile.
Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.