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Orthosoft Inc

CanadaFDA applicant, unverified

Part of Orthosoft

Devices
350

What Orthosoft Inc makes

Orthosoft Inc produces orthopaedic positioning instruments for joint prosthesis implantation, including single-use and reusable guides for shoulder, hip, and knee procedures. Their portfolio also includes robotic surgical navigation systems, osteotomy guides, and application software for radiology image processing and surgical planning. Sterilization containers for reusable devices and joint prosthesis implantation kits are also part of their offerings.

The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories, and are listed under the 510(k) and UDI programs. These products are available in the United States, where the manufacturer is based.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

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Company details

DUNS number
205670032
Phone
1(800)348-2759

Frequently asked questions

How many devices does Orthosoft Inc have in the registry?

The registry currently lists 350 devices for Orthosoft Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Orthosoft Inc's devices?

Among its 50 most recently registered devices, Orthosoft Inc has devices listed in FDA GUDID (50 devices).

What risk classes do Orthosoft Inc's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Orthosoft Inc's devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Orthosoft Inc in the registry?

The most recently registered devices listed for Orthosoft Inc include Sesamoid® System 20-8000-000-01, Sesamoid® System 20-8000-000-02, ROSA® Robotics 20-8000-010-06 and ROSA® Robotics 20-8000-010-33.

Generated automatically from registry data and not verified by a human reviewer.