In2bones USA, LLC
FDA Regulatory Profile
In2bones USA, LLC appears in FDA public data with 5 recalls, 27 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2355-2026, Class II) was initiated on May 11, 2026. Its most recent 510(k) clearance was granted on May 30, 2026.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 27
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2355-2026 | Class II | NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 | May 11, 2026 |
| Z-2506-2021 | Class II | CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general i | August 18, 2021 |
| Z-0670-2019 | Class II | NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010 | November 14, 2018 |
| Z-2880-2018 | Class II | CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2 | July 16, 2018 |
| Z-2879-2018 | Class II | CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In | July 16, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261154 | CoLink® & CoLag® Non-Sterile Screws | May 30, 2026 |
| K241387 | CoLink NeoFuse MIS Plating System (see attached parts list) | August 13, 2024 |
| K233089 | NeoSpan® Compression Implant System | May 24, 2024 |
| K231236 | IBS-B MIS Beveled Screw System | July 27, 2023 |
| K213698 | CoLink PCR Plating System | May 27, 2022 |
| K220260 | Hercules Syndesmosis Implant System | March 31, 2022 |
| K212872 | Avenger Radial Head System | December 17, 2021 |
| K213069 | CoLink NeoFuse Plating System | December 13, 2021 |
| K212487 | CoLink Vallux Plating System | November 18, 2021 |
| K203698 | CoLink Sfx Implant System | May 4, 2021 |
| K210060 | CoLink Mfx Implant System | March 12, 2021 |
| K201636 | Hercules Suture Anchor System | August 20, 2020 |
| K201149 | CoLink Plating System | July 15, 2020 |
| K200762 | CoLink Cfx Plating System | April 23, 2020 |
| K193543 | CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plati | January 17, 2020 |
| K192754 | Avenger Radial Head System | January 7, 2020 |
| K190385 | CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Stapl | August 8, 2019 |
| K191535 | CoLink® Mini Plating System | July 29, 2019 |
| K182402 | CoLink View Plating System | September 27, 2018 |
| K180377 | Fracture and Correction System | June 20, 2018 |