FDA Registration
Active
🇫🇷 France
In2Bones SAS
Reg #: 3010470577
·
FEI: 3010470577
·
Expires 2026
Products
32
Proprietary Names
43
Establishment Types
2
Classifications
32
Registration Details
- Registration Name
- In2Bones SAS
- Registration Number
- 3010470577
- FEI Number
- 3010470577
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Immeuble Sequoia 3, 97 Allee Alexandre Borodine
- City
- Saint-Priest Rhone
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K170594
Owner / Operator
- Firm Name
- In2Bones SAS
- Operator Number
- 10046803
- Address
- 97, Allee Alexandre Borodine, Immeuble SEQUOIA 3
- City
- Saint Priest
- State
- Rhone
- Postal Code
- 69800
- Country
- FR
- Correspondent
- Lydia Bedre-dine
US Agent
- Business Name
- ConMed Corporation
- Contact Name
- Kathryn Reddig
- Address
- 11311 Concept Blvd
- City
- Largo
- State
- FL
- ZIP
- 33773
- Country
- US
- [email protected]
- Phone
- 727 3995562
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2018-06-11 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2017-12-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-05-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-12-22 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2016-05-31 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2025-11-19 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-02-08 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2025-11-19 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2018-09-12 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-11-19 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Starter, Bone Screw | HWD | Class 1 | Orthopedic | No | 2014-12-22 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2021-11-04 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-11-19 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2025-11-19 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2014-12-22 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2016-10-20 |
| Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | HSN | Class 2 | Orthopedic | No | 2020-03-06 |
| Ankle Arthroplasty Implantation System | OYK | Class 2 | Orthopedic | No | 2021-11-04 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2014-12-22 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-03-07 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2016-03-07 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-12-22 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2017-12-11 |
| Template | HWT | Class 1 | Orthopedic | No | 2016-10-20 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2018-03-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-10-20 |
Proprietary Names
AKILINK
PIT'Stop
I.B.S osteosynthesis screws
All manual instruments
OS2-VP Varisation Staple
OS2-V Varisation Staple
TUBE FOR KWIRE
Ankle Fusion Plating System
GENERIC LID REUSABLE INSTRUMENTS
Drill bits
Percutaneous Burr
QUANTUM drill
Measurer, rulers, calipers
SolaFix Snap-Off Screws
I.B.S. Snap-Off Screws
Handle
NEOSYS and DUAFIT - single use instrument kit
NEOMIS
Starter
Quantum
NEOFIT PLATE BENDER RIGHT
COMPRESSOR/DISTRACTOR
I.B.S. Neutralization Screws
I.B.S. Osteosynthesis Screws
I.B.S. Compression Screws
SolaFix Neutralization Screws
SolaFix Osteosynthesis Screws
SolaFix Compression Screws
Measurer, depth guage
Interphalangeal Implant (DUAFIT)
Driver, Posthesis
Quantum Total Ankle Prosthesis
Quantum PSI
K-wires (when used as guides), protector tubes, guides, sleeves...
Screwdriver tip
reamer
Screwdriver
I.B.S. 2 Osteosynthesis Screw
In2Bones Kirschner wire
trays
Template
TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
Awl
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility