In2bones USA, LLC
Medical device manufacturer in Cordova, TN.
27510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | 05/30/2026SE |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list)HRS · Traditional | 08/13/2024SE |
| K233089 | NeoSpan® Compression Implant SystemHRS · Traditional | 05/24/2024SE |
| K231236 | IBS-B MIS Beveled Screw SystemHWC · Traditional | 07/27/2023SE |
| K213698 | CoLink PCR Plating SystemHRS · Traditional | 05/27/2022SE |
| K220260 | Hercules Syndesmosis Implant SystemHTN · Traditional | 03/31/2022SE |
| K212872 | Avenger Radial Head SystemKWI · Traditional | 12/17/2021SE |
| K213069 | CoLink NeoFuse Plating SystemHRS · Traditional | 12/13/2021SE |
| K212487 | CoLink Vallux Plating SystemHRS · Traditional | 11/18/2021SE |
| K203698 | CoLink Sfx Implant SystemHTY · Traditional | 05/04/2021SE |
| K210060 | CoLink Mfx Implant SystemHRS · Traditional | 03/12/2021SE |
| K201636 | Hercules Suture Anchor SystemMBI · Traditional | 08/20/2020SE |
| K201149 | CoLink Plating SystemHRS · Traditional | 07/15/2020SE |
| K200762 | CoLink Cfx Plating SystemHRS · Traditional | 04/23/2020SE |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System…HRS · Special | 01/17/2020SE |
| K192754 | Avenger Radial Head SystemKWI · Traditional | 01/07/2020SE |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan…HRS · Traditional | 08/08/2019SE |
| K191535 | CoLink® Mini Plating SystemHRS · Traditional | 07/29/2019SE |
| K182402 | CoLink View Plating SystemHRS · Special | 09/27/2018SE |
| K180377 | Fracture and Correction SystemHWC · Traditional | 06/20/2018SE |
| K181113 | CoLink Afx Plating SystemHRS · Traditional | 06/15/2018SE |
| K173491 | RTS Lesser MTP Implant SystemKWH · Traditional | 02/23/2018SE |
| K172300 | CoLink View Plating SystemHRS · Traditional | 11/27/2017SE |
| K170518 | In2Bones Fracture and Correction SystemHRS · Traditional | 07/14/2017SE |
| K163293 | Colink Plating SystemHRS · Traditional | 05/05/2017SE |
| K161426 | NeoSpan Compression Staple Impant w/instrumentsJDR · Traditional | 10/24/2016SE |
| K153609 | RTS Flexible 1 MPJ Implant w/GrommetsKWH · Traditional | 09/08/2016SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2355-2026 Class II | NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name…Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. | 05/11/2026Open, Classified |
| Z-2506-2021 Class II | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is…Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site. | 08/18/2021Terminated |
| Z-0670-2019 Class II | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50…The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain… | 11/14/2018Terminated |
| Z-2880-2018 Class II | CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage:…CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates… | 07/16/2018Terminated |
| Z-2879-2018 Class II | CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage:…CoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates… | 07/16/2018Terminated |