510(k) K161426 ยท JDR Staple, Fixation, Bone
NeoSpan Compression Staple Impant w/instruments
| Applicant | In2bones USA, LLC, Memphis TN, US |
| Decision | Substantially Equivalent, Oct 24, 2016 |
| Received | May 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161426
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 8, 2026 | In2bones USA, LLC NeoSpan SuperElastic Compression Staple w/Instruments
Catalog Number and Product Name
T50 SN010 NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10
UDI-DI Code: 00817906020083
T50 S Open, Classified |
JDR | None listed |
| Nov 14, 2018 | In2bones USA, LLC NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.