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B2b Spine Pty, Ltd.

Country not established

Devices
1

What B2b Spine Pty, Ltd. makes

B2b Spine Pty, Ltd. manufactures the DYMAXEON SPINE SYSTEM, a spinal implant designed for surgical applications in the spine.

The company’s portfolio is regulated under FDA Class II devices, with the DYMAXEON SPINE SYSTEM listed via the 510(k) pathway. The manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Dymaxeon Spine System Ref K121786

    Class II
    Active 510(k) 510(k) II

Frequently asked questions

How many devices does B2b Spine Pty, Ltd. have in the registry?

The registry currently lists 1 device for B2b Spine Pty, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list B2b Spine Pty, Ltd.'s devices?

Among its 1 most recently registered device, B2b Spine Pty, Ltd. has devices listed in FDA 510(k) (1 device).

What risk classes do B2b Spine Pty, Ltd.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for B2b Spine Pty, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from B2b Spine Pty, Ltd. in the registry?

The most recently registered devices listed for B2b Spine Pty, Ltd. include DYMAXEON SPINE SYSTEM.

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