510(k) K201393 ยท KWD Prosthesis, Toe, Hemi-, Phalangeal
restor3d MTP Implant
| Applicant | Restor3D, Inc., Durham NC, US |
| Decision | Substantially Equivalent, May 25, 2022 |
| Received | May 27, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201393
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | restor3d Inc. Generic Name: restor3d MTP Implant
Generic Name: MTP Implant
Model/Catalog Number: 1103-161620
Software Version: None
Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, Open, Classified |
KWD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.