Company ยท US
Wishbone Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2023. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 16, 2023 | K231461 | Smart Correction System (HA Half Pins) Wishbone Medical, Inc. | KTT |
| Mar 29, 2023 | K230527 | WishBone Medical Plate and Screw System Wishbone Medical, Inc. | HRS |
| Jun 6, 2022 | K221366 | Smart Correction System Rings and Compatible HA-Coated Half Pins Wishbone Medical, Inc. | KTT |
| Jan 27, 2022 | K213489 | Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate Wishbone Medical, Inc. | HRS |
| Dec 23, 2020 | K203467 | WishBone Medical Plate and Screw System Wishbone Medical, Inc. | HWC |
| Sep 18, 2020 | K193368 | Smart Correction System Wishbone Medical, Inc. | KTT |
| Jun 25, 2019 | K182704 | WishBone Guided Growth System Wishbone Medical | OBT |
| Oct 4, 2018 | K180736 | WishBone Medical Plate and Screw System Wishbone Medical, Inc. | HRS |
| Dec 14, 2017 | K173013 | WishBone K-Wire System Wishbone Medical, Inc. | HTY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2024 | Wishbone Medical, Inc. WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device. Open, Classified |
OBT | K182704 |
| 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 | K193368 |
| 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 | K180736 |