Wishbone Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1808-2024Class IIWishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.April 5, 2024
Z-1102-2023Class IIWishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device TyJanuary 4, 2023
Z-1794-2021Class IIWishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PKApril 30, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K231461Smart Correction System (HA Half Pins)June 16, 2023
K230527WishBone Medical Plate and Screw SystemMarch 29, 2023
K221366Smart Correction System Rings and Compatible HA-Coated Half PinsJune 6, 2022
K213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateJanuary 27, 2022
K203467WishBone Medical Plate and Screw SystemDecember 23, 2020
K193368Smart Correction SystemSeptember 18, 2020
K182704WishBone Guided Growth SystemJune 25, 2019
K180736WishBone Medical Plate and Screw SystemOctober 4, 2018
K173013WishBone K-Wire SystemDecember 14, 2017