Bofors Nobelpharma, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Bofors Nobelpharma, Inc. makes
Bofors Nobelpharma, Inc. manufactures orthopedic surgical tools and implants, including a tissue-integrated prosthesis drill for precise bone preparation, titanium implant devices for joint replacement, and osseointegrated fixtures designed for tissue integration in prosthetic applications.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) clearance registry. The manufacturer operates from the United States.
Catalogue
Tissue Integrated Prosthesis Drill Ref K841813
Regimes: 510(k) Registry: 510(k)Titanium Implant Devices Ref K820013
Regimes: 510(k) Registry: 510(k)Osseointegrated Fixtures-Tissue Integr Ref K841551
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bofors Nobelpharma, Inc. have in the registry?
The registry currently lists 3 devices for Bofors Nobelpharma, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bofors Nobelpharma, Inc.'s devices?
Among its 3 most recently registered devices, Bofors Nobelpharma, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bofors Nobelpharma, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bofors Nobelpharma, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bofors Nobelpharma, Inc. in the registry?
The most recently registered devices listed for Bofors Nobelpharma, Inc. include TISSUE INTEGRATED PROSTHESIS DRILL, TITANIUM IMPLANT DEVICES and OSSEOINTEGRATED FIXTURES-TISSUE INTEGR.