510(k) K193368 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Smart Correction System
| Applicant | Wishbone Medical, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 18, 2020 |
| Received | Dec 5, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193368
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2023 | Wishbone Medical, Inc. WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device
Type Part Number
XXS 10-702-080095-0
XS 10-702-095115-0
Short 10-7 Open, Classified |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.