Bregma International Trading Company, Ltd.
CanadaFDA applicant, unverified
- Devices
- 3
What Bregma International Trading Company, Ltd. makes
Bregma International Trading Company, Ltd. manufactures orthopedic fixation devices, including bone screws, stainless steel soft suture wire, and stainless steel fixation pins. These products are designed for surgical applications requiring secure bone or tissue attachment.
The company’s portfolio is regulated under FDA Class II devices and is listed in the 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Bone Screws Ref K990351
Regimes: 510(k) Registry: 510(k)Stainless Steel Soft Suture Wire Ref K990355
Regimes: 510(k) Registry: 510(k)Stainless Steel Fixation Pins Ref K990353
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bregma International Trading Company, Ltd. have in the registry?
The registry currently lists 3 devices for Bregma International Trading Company, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bregma International Trading Company, Ltd.'s devices?
Among its 3 most recently registered devices, Bregma International Trading Company, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bregma International Trading Company, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bregma International Trading Company, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bregma International Trading Company, Ltd. in the registry?
The most recently registered devices listed for Bregma International Trading Company, Ltd. include BONE SCREWS, STAINLESS STEEL SOFT SUTURE WIRE and STAINLESS STEEL FIXATION PINS.