Blue Belt Technologies, Inc.
United StatesFDA applicant, unverified FDA FEI 3016090213
- Devices
- 78
- Registrations
- FDA
- FDA recalls
- 33 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
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.
Catalogue
Search and filter all 78 devicesShowing 1-50 of 78
Company details
- FDA FEI number
- 3016090213
- DUNS number
- 015299627
- Address
- 2875 Railroad Street, Pittsburgh, PA, 15222
- [email protected]
- Phone
- 763-452-4910
FDA recalls
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.
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
Full distribution text
- 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
2023
- 13 Nov 2023 Z-0708-2024 Class II Ongoing Possibility that the user is unable to resolve drill disconnection error messages.
- 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
Frequently asked questions
How many devices does Blue Belt Technologies, Inc. have in the registry?
The registry currently lists 78 devices for Blue Belt Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Blue Belt Technologies, Inc.'s devices?
Among its 50 most recently registered devices, Blue Belt Technologies, Inc. has devices listed in FDA GUDID (50 devices).
What risk classes do Blue Belt Technologies, Inc.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Blue Belt Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Blue Belt Technologies, Inc.?
FDA recall records list 3 recalls initiated by Blue Belt Technologies, Inc., the most recent initiated on 2024-05-07. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Blue Belt Technologies, Inc. in the registry?
The most recently registered devices listed for Blue Belt Technologies, Inc. include STRIDE Unicondylar Knee 110059, STRIDE Unicondylar Knee 110074, STRIDE Unicondylar Knee 110030 and STRIDE Unicondylar Knee 110066.