FDA Registration
Active
🇺🇸 United States
IN2BONES USA, LLC
Reg #: 3011580264
·
FEI: 3011580264
·
Expires 2026
Products
14
Proprietary Names
30
Establishment Types
3
Classifications
14
Registration Details
- Registration Name
- IN2BONES USA, LLC
- Registration Number
- 3011580264
- FEI Number
- 3011580264
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 7750a Trinity Rd
- City
- Cordova
- State
- TN
- ZIP
- 38018
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200762
Owner / Operator
- Firm Name
- In2Bones USA, LLC
- Operator Number
- 10049042
- Address
- 7750A Trinity Road
- City
- Cordova
- State
- TN
- Postal Code
- 38018
- Country
- US
- Correspondent
- Kathryn Reddig
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-04-24 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-04-24 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-07-20 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2020-10-28 |
| Prosthesis, Toe, Constrained, Polymer | KWH | Class 2 | Orthopedic | No | 2018-03-02 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-03-08 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2021-01-05 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2021-12-18 |
| Template | HWT | Class 1 | Orthopedic | No | 2018-03-08 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2024-08-05 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2021-05-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-06-03 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2019-09-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2021-01-05 |
Proprietary Names
CoLink Cfx Plating System
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
NeoSpan
RTS System
AlloAid
General Instrument
CoLink Vallux Plating System
CoLink Afx Plating System
IBS-B MIS Beveled Screw System
Avenger Radial Head
NeoSpan Compression Implant System
CoLink Sfx Implant System
RTS 1st MPJ Implant
CoLink NeoFuse Plating System
In2Bones USA, LLC
Avenger Radial Head System
NeoSpan Compression Staple Implant
CoLink
CoLag
CoLink Mfx Plating System
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device