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
Phone
727 3995562

Products

Device Name Product Code
Instrument, Ligature Passing And Knot Tying HCF
Impactor HWA
Screw, Fixation, Bone HWC
Orthopedic Manual Surgical Instrument LXH
Staple, Fixation, Bone JDR
Forceps, Wire Holding HYA
Plate, Fixation, Bone HRS
Staple Driver HXJ
Bit, Surgical GFG
Bur, Surgical, General & Plastic Surgery GFF
Bit, Drill HTW
Tape, Measuring, Rulers And Calipers FTY
Handle, Scalpel GDZ
Kit, Surgical Instrument, Disposable KDD
Starter, Bone Screw HWD
Reamer HTO
Bender HXW
Clamp HXD
Gauge, Depth HTJ
Driver, Prosthesis HWR
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
Ankle Arthroplasty Implantation System OYK
Guide, Surgical, Instrument FZX
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Screwdriver HXX
Pin, Fixation, Smooth HTY
Pin, Fixation, Threaded JDW
Tray, Surgical, Instrument FSM
Positioner, Socket KIL
Template HWT
Rod, Fixation, Intramedullary And Accessories HSB
Awl HWJ

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