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Northern Orthopaedic Products, Inc.

United StatesFDA applicant, unverified

Devices
2

What Northern Orthopaedic Products, Inc. makes

Northern Orthopaedic Products, Inc. manufactures the HAMEX ONE and HAMEX TWO, which are orthopaedic fixation devices designed for internal bone stabilization. These products are intended for use in surgical procedures to support fracture repair or bone reconstruction, providing mechanical support during the healing process.

The company’s devices fall under Class I classification in the US regulatory framework, with each product authorised through the FDA’s 510(k) pathway. The portfolio is listed under the US Food and Drug Administration’s regulatory system, adhering to applicable medical device standards for internal fixation hardware.

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

Catalogue2

Newest first, rows 1-2 of 2

  • Hamex Two Ref K951028

    Active Regimes: 510(k) Registry: 510(k) Class:I
  • Hamex One Ref K951029

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

Frequently asked questions

How many devices does Northern Orthopaedic Products, Inc. have in the registry?

The registry currently lists 2 devices for Northern Orthopaedic Products, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Northern Orthopaedic Products, Inc.'s devices?

Among its 2 most recently registered devices, Northern Orthopaedic Products, Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Northern Orthopaedic Products, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Northern Orthopaedic Products, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Northern Orthopaedic Products, Inc. in the registry?

The most recently registered devices listed for Northern Orthopaedic Products, Inc. include HAMEX TWO and HAMEX ONE.

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