In2bones USA, LLC
In2bones USA, LLC holds FDA 510(k) medical device clearances, first cleared 2016, most recent 2026, with 5 FDA device recalls on record.
Name variants for In2bones USA, LLC
as filed with FDA- In2bones USA, LLC
- In2Bones USA, LLC
Top product codes for In2bones USA, LLC
FDA recalls by In2bones USA, LLC
- Z-2355-2026 — NeoSpan¿ SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x10x10 UDI-DI Code: 00817906020083 T50 SN012 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 12x12x12 UDI-DI Code: 00817906020090 T50 SN020 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 20x20x20 UDI-DI Code: 00817906020151 T50 SN110 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 10x15x13 UDI-DI Code: 00817906020113 T50 SN115 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 15Wx15x15 UDI-DI Code: 00817906020137 T50 SN118 NeoSpan¿ SuperElastic Compression Staple w/Instruments, Size 18x14x14 UDI-DI Code: 00810021861364 Single/multiple component metallic bone fixation appliances and accessories The In2Bones USA NeoSpan" Compression Staple Implant w/instruments is indicated for hand and foot bone fragments, osteotomy fixation and joint arthrodesis.
- Z-2506-2021 — CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
- Z-0670-2019 — NeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010
- Z-2880-2018 — CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
- Z-2879-2018 — CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones Product Usage: The In2Bones USA LLC, CoLink¿ Plating System is indicated for stabilization and fixation of fractures, revision procedures, joint fusion, osteotomies and reconstruction of the small bones in the hand, wrist, foot and ankle in both pediatric and adult patients.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by In2bones USA, LLC
- K261154 — CoLink® & CoLag® Non-Sterile Screws
- K233089 — NeoSpan® Compression Implant System
- K231236 — IBS-B MIS Beveled Screw System
- K213698 — CoLink PCR Plating System
- K220260 — Hercules Syndesmosis Implant System
- K212872 — Avenger Radial Head System
- K213069 — CoLink NeoFuse Plating System
- K212487 — CoLink Vallux Plating System
- K203698 — CoLink Sfx Implant System
- K210060 — CoLink Mfx Implant System
- K201636 — Hercules Suture Anchor System
- K201149 — CoLink Plating System
- K200762 — CoLink Cfx Plating System
- K193543 — CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System
- K192754 — Avenger Radial Head System
- K190385 — CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System
- K191535 — CoLink® Mini Plating System
- K182402 — CoLink View Plating System
- K180377 — Fracture and Correction System
- K181113 — CoLink Afx Plating System
- K173491 — RTS Lesser MTP Implant System
- K172300 — CoLink View Plating System
- K170518 — In2Bones Fracture and Correction System
- K163293 — Colink Plating System
- K161426 — NeoSpan Compression Staple Impant w/instruments
- K153609 — RTS Flexible 1 MPJ Implant w/Grommets
Data sourced from openFDA. This site is unofficial and independent of the FDA.