510(k) K213530 ยท HWC Screw, Fixation, Bone
Nextra CH Cannulated Hammertoe System
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 9, 2021 |
| Received | Nov 5, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2022 | Nextremity Solutions Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes
SKU: CH-MINI-KT Terminated |
HWC | None listed |
| Jan 13, 2022 | Nextremity Solutions Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toe
SKU: CH-STD-KT Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.