EU → North America Device Access

In2Bones SAS

FR-MF-000005246 · France · Saint Priest

In2Bones SAS is registered in the European database on medical devices as a manufacturer, with 467 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa282
Class IIb185

Most frequent device types declared: A06 10011, M05 00013, M05 00143, M05 00771, M05 00811.

Among these devices, 215 are declared sterile, 184 implantable, 134 reusable, 13 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 467 declared devices.

Catalogue references include G02 10031, K10 NS220, M05 00175, M05 00217, M05 10015, N02 00018.

European nomenclature codes declared: L091199, L091002, P09120503, P09120299, P09120301, P091399.

United States market access

FDA establishment registerRegistered with FDA
Matched entryIn2Bones SAS (FR) · FDA 3010470577
Devices in EUDAMED467
Country of registrationFrance

Device-level evidence

Devices with a numeric GTIN467
Found in the U.S. device database467
Share100.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryIN2BONES USA

⚠️ A similar name exists; unverified — why.

What it holds in Canada

Licences on record17
Currently active0
Class 2 devices6
Class 3 devices11
First licensed2022-10-24

Licence types: System (12), Device Family (2), Device Group Family (2), Device Group (1).

Licensed under: BONE GRAFT HARVESTER, NEOSPAN SUPERELASTIC COMPRESSION STAPLE WITH I, COLINK SFX IMPLANT SYSTEM, RTS SILICONE TOE SYSTEM, COLINK NEOFUSE PLATING SYSTEM, COLINK AFX PLATING SYSTEM.

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