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Blue Belt Technologies, Inc.

United StatesFDA applicant, unverified FDA FEI 3016090213

Devices
78
Registrations
FDA
FDA recalls
33 ongoing

What Blue Belt Technologies, Inc. makes

Blue Belt Technologies, Inc. manufactures orthopedic surgical systems and pre-operative planning software. Their product portfolio includes the NAVIO and Real Intelligence CORI surgical systems, as well as the RI.HIP MODELER and CORIOGRAPH pre-operative planning and modeling services.

The company is based in the United States, and its devices are classified as Class II medical devices. These products are listed in the FDA 510(k) regulatory registry.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue78

Newest first, rows 51-78 of 78

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  • STRIDE Unicondylar Knee 110054

    Withdrawn Registry: GUDID Class:II

  • STRIDE Unicondylar Knee 110051

    Withdrawn Registry: GUDID Class:II

  • STRIDE Unicondylar Knee 110044

    Withdrawn Registry: GUDID Class:II

  • STRIDE Unicondylar Knee 110029

    Withdrawn Registry: GUDID Class:II

  • STRIDE Unicondylar Knee 110061

    Withdrawn Registry: GUDID Class:II

  • STRIDE Unicondylar Knee 110026

    Withdrawn Registry: GUDID Class:II

  • Ri.hip Modeler Ref K212040

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

  • CORIOGRAPH Pre-Op Planning and Modeling Services Ref K250921

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

  • Real Intelligence Cori Ref K193120

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

  • Real Intelligence Cori Ref K220958

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

  • Navio Ref K191223

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

  • Real Intelligence™ CORI™ Ref K240139 Open recall

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

  • Navio Ref K140596

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

  • Navio Ref K160537

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

  • Navio Ref K152574

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

  • Real Intelligence Cori Ref K221224

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

  • Real Intelligence™ Cori™ Ref K231963 Open recall

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

  • Real Intelligence™ Cori™ Ref K260601

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

  • Stride Unicondylar Knee Ref K123380

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

  • Real Intelligence Cori (Cori) Ref K201022

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

  • Naviopfs Ref K121936

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

  • Navio Ref K170360

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

  • Real Intelligence Cori Ref K220255

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

  • NAVIO™ Surgical System (NAVIO system) Ref K180271

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

  • Real Intelligence Cori (Cori) Ref K212537

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

  • Real Intelligence™ Cori™ Xt (Cori Xt) Ref K252841

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

  • Navio Ref K143668

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

  • CORIOGRAPH Pre-Op Planning and Modeling Services Ref K242272

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

Rows 51-78 of 78

Showing 51-78 of 78

Company details

FDA FEI number
3016090213
DUNS number
015299627
Address
2875 Railroad Street, Pittsburgh, PA, 15222
Phone
763-452-4910

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by Blue Belt Technologies, Inc., the earliest on 2023-09-07 and the most recent on 2024-05-07. By recorded status: 3 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 2
  • 2024 1
  • 2025 0
  • 2026 0

  • 2024

    • 7 May 2024 Z-2135-2024 Class II Ongoing CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Error (MRE) which may cause tracker arrays to flicker on screen of the CORI Surgical System during use, and may cause surgical delay Distribution: Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany,…
      Full distribution text Nationwide Foreign: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, UK
      Submission number: K240139

  • 2023

    • 13 Nov 2023 Z-0708-2024 Class II Ongoing Possibility that the user is unable to resolve drill disconnection error messages. Distribution: Domestic: Nationwide Distribution. Submission number: K231963
    • 7 Sep 2023 Z-0041-2024 Class II Ongoing CORI software was missing a planning stage that appears in cases of significant knee deformation (outside of the range of 3 degrees valgus to 7 degrees varus) when the surgeon chooses to define the femoral rotational reference via the posterior condylar axis Distribution: US Nationwide distribution. Submission number: K231963