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Ortopedia GmbH

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Devices
1

What Ortopedia GmbH makes

Ortopedia GmbH manufactures the MONOFIXATEUR, a medical device designed for orthopedic fixation applications, likely used in bone stabilization procedures.

The MONOFIXATEUR is classified as a Class II device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Monofixateur Ref K854336

    Active Regimes: 510(k) Registry: 510(k) Class:II

Frequently asked questions

How many devices does Ortopedia GmbH have in the registry?

The registry currently lists 1 device for Ortopedia GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list Ortopedia GmbH's devices?

Among its 1 most recently registered device, Ortopedia GmbH has devices listed in FDA 510(k) (1 device).

What risk classes do Ortopedia GmbH's devices fall under?

Among its 1 most recently registered device, the classes recorded for Ortopedia GmbH's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Ortopedia GmbH in the registry?

The most recently registered devices listed for Ortopedia GmbH include MONOFIXATEUR.

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