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In2bones USA, LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
26
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2506-2021Class IICoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general iAugust 18, 2021
Z-0670-2019Class IINeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010November 14, 2018
Z-2880-2018Class IICoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2July 16, 2018
Z-2879-2018Class IICoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The InJuly 16, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K241387CoLink NeoFuse MIS Plating System (see attached parts list)August 13, 2024
K233089NeoSpan® Compression Implant SystemMay 24, 2024
K231236IBS-B MIS Beveled Screw SystemJuly 27, 2023
K213698CoLink PCR Plating SystemMay 27, 2022
K220260Hercules Syndesmosis Implant SystemMarch 31, 2022
K212872Avenger Radial Head SystemDecember 17, 2021
K213069CoLink NeoFuse Plating SystemDecember 13, 2021
K212487CoLink Vallux Plating SystemNovember 18, 2021
K203698CoLink Sfx Implant SystemMay 4, 2021
K210060CoLink Mfx Implant SystemMarch 12, 2021
K201636Hercules Suture Anchor SystemAugust 20, 2020
K201149CoLink Plating SystemJuly 15, 2020
K200762CoLink Cfx Plating SystemApril 23, 2020
K193543CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View PlatiJanuary 17, 2020
K192754Avenger Radial Head SystemJanuary 7, 2020
K190385CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression StaplAugust 8, 2019
K191535CoLink® Mini Plating SystemJuly 29, 2019
K182402CoLink View Plating SystemSeptember 27, 2018
K180377Fracture and Correction SystemJune 20, 2018
K181113CoLink™ Afx Plating SystemJune 15, 2018