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Data / Medical devices / United States / In2bones Usa, LLC

In2bones Usa, LLC: FDA-registered device maker in Cordova, TN, United States, 22 510(k) clearances

In2bones Usa, LLC is registered with the FDA (registration 3011580264) in Cordova, TN, United States. It lists 13 device types. The FDA files 22 510(k) clearances under its listings, the newest dated May 30, 2026. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch In2bones Usa, LLC
FDA registration number
3011580264
Address
7750a Trinity Rd, Cordova, TN, United States, 38018
Owner or operator
In2Bones USA, LLC (10049042)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
September 21, 2016
Registered through
2027
Brand names listed
5MS Plating System, AlloAid, CoLag, CoLag System, CoLink, CoLink Afx Plating System, CoLink Cfx Plating System, CoLink Mfx Plating System and more

Devices it lists

DeviceProduct codeClassRoleSource
Driver, ProsthesisHWR1Specification developeraccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Specification developeraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Passer, Wire, OrthopedicHXI1Specification developeraccessdata.fda.gov
Pin, Fixation, SmoothHTY2Specification developeraccessdata.fda.gov
Plate, Fixation, BoneHRS2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Prosthesis, Toe, Constrained, PolymerKWH2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Staple, Fixation, BoneJDR2Manufacturer, Specification developeraccessdata.fda.gov
TemplateHWT1Manufacturer, Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Washer, Bolt NutHTN2Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
May 30, 2026K261154CoLink® & CoLag® Non-Sterile ScrewsHWCSubstantially EquivalentIn2Bones USA, LLCaccessdata.fda.gov
May 24, 2024K233089NeoSpan® Compression Implant SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
July 27, 2023K231236IBS-B MIS Beveled Screw SystemHWCSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
May 27, 2022K213698CoLink PCR Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
March 31, 2022K220260Hercules Syndesmosis Implant SystemHTNSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
December 13, 2021K213069CoLink NeoFuse Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
November 18, 2021K212487CoLink Vallux Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
May 4, 2021K203698CoLink Sfx Implant SystemHTYSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
March 12, 2021K210060CoLink Mfx Implant SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
August 20, 2020K201636Hercules Suture Anchor SystemMBISubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
July 15, 2020K201149CoLink Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
April 23, 2020K200762CoLink Cfx Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
July 29, 2019K191535CoLink® Mini Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
September 27, 2018K182402CoLink View Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
June 20, 2018K180377Fracture and Correction SystemHWCSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
June 15, 2018K181113CoLink™ Afx Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
February 23, 2018K173491RTS Lesser MTP Implant SystemKWHSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
November 27, 2017K172300CoLink View Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
July 14, 2017K170518In2Bones Fracture and Correction SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
May 5, 2017K163293Colink™ Plating SystemHRSSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
October 24, 2016K161426NeoSpan Compression Staple Impant w/instrumentsJDRSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov
September 8, 2016K153609RTS Flexible 1 MPJ Implant w/GrommetsKWHSubstantially EquivalentIn2bones USA, LLCaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
September 9, 202699846Class IIOngoingREF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmDue to labeling error, bone screws specified as fully threaded, are actually partially threaded screws.accessdata.fda.gov
May 11, 202698978Class IIOngoingNeoSpan 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 SuperElasDue to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.accessdata.fda.gov
August 18, 202188510Class IITerminatedCoLink 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.Complaints were received of CoLink Bone Graft Harvesters breaking at the outer tube weld site.accessdata.fda.gov
November 14, 201881655Class IITerminatedNeoSpan SuperElastic Compression Staple w/Instruments, Size 10x10x10, Part Number T50 SN010The NeoSpan Compression Staple (10x10x10) kits from two lots contain the wrong size drill bit. They contain a 3mm drill bit instead of a 2mm drill bit.accessdata.fda.gov
July 16, 201880618Class IITerminatedCoLink(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 fuCoLink(TM) Lapidus Plate +2mm Right and Left, were laser marked incorrectly. In these lots, right plates were laser marked as left plates and the left plates were laser marked as right plates.accessdata.fda.gov

Compare with other makers

Updated October 14, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.