Bonafix Surgical and Dental Implants, LLC
United StatesFDA applicant, unverified
- Devices
- 3
What Bonafix Surgical and Dental Implants, LLC makes
Bonafix Surgical and Dental Implants, LLC manufactures orthopedic fixation devices, including the MINIFIX BALL and MINIFIX ONE systems for bone stabilization, as well as the ORTHOFIX SCREW for surgical applications in orthopedic surgery.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records in the United States.
Catalogue
Bonafix TWO - Dental Implant System Ref K162853
Regimes: 510(k) Registry: 510(k)Minifix Ball Minifix One Ref K122052
Regimes: 510(k) Registry: 510(k)Orthofix Screw Ref K113650
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bonafix Surgical and Dental Implants, LLC have in the registry?
The registry currently lists 3 devices for Bonafix Surgical and Dental Implants, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bonafix Surgical and Dental Implants, LLC's devices?
Among its 3 most recently registered devices, Bonafix Surgical and Dental Implants, LLC has devices listed in FDA 510(k) (3 devices).
What risk classes do Bonafix Surgical and Dental Implants, LLC's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bonafix Surgical and Dental Implants, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bonafix Surgical and Dental Implants, LLC in the registry?
The most recently registered devices listed for Bonafix Surgical and Dental Implants, LLC include Bonafix TWO - Dental Implant System, MINIFIX BALL MINIFIX ONE and ORTHOFIX SCREW.