Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011580264

FEI Number

3011580264

Entity Name

IN2BONES USA, LLC

City/State/Country

Cordova, TN, US

Establishment Address

7750a Trinity Rd, Cordova, TN 38018, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

In2Bones USA, LLC (Owner Number: 10049042)

Owner / Operator Contact Address

7750A Trinity Road, Cordova, TN 38018, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CoLink Cfx Plating System CoLink View CoLink View CoLink Plating System Hercules Suture Anchor System Hercules Syndesmosis Implant System Fracture and Correction System CoLink Mini Plating System RTS Lesser MTP Implant System CoLag System In2Bones Fracture & Correction System 5MS Plating System CoLink PCR Plating System CoLink Plating System In2Bones Fracture & Correction System NeoSpan RTS System AlloAid General Instrument CoLink Plating System CoLink Vallux Plating System CoLink Afx Plating System IBS-B MIS Beveled Screw System Avenger Radial Head In2Bones Fracture & Correction System CoLink Plating System RTS System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-04-24
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-04-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-11-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-11-14
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-03-08
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2020-07-20
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-07-20
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-07-20
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2020-10-28
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2022-04-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-06-25
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-06-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-08-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-08-07
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	Class 2	888.3720	2018-03-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-07-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-07-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-06-02
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-03-08
HWR	Driver, Prosthesis	Orthopedic	Class 1	888.4540	2021-01-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2017-05-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-05-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-12-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-12-13
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-06-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-06-25
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-09
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer	Orthopedic	Class 2	888.3170	2021-12-18
HWT	Template	Orthopedic	Class 1	888.4800	2018-03-08

Official Correspondent

Kathryn Reddig

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

In2Bones USA, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011580264. Last updated year: 2026. Please use registration number 3011580264 when referencing this establishment in official correspondence.