510(k) K180736 ยท HRS Plate, Fixation, Bone
WishBone Medical Plate and Screw System
| Applicant | Wishbone Medical, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 4, 2018 |
| Received | Mar 22, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2021 | Wishbone Medical, Inc. WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut.
Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.