Dfine, Inc.
United StatesFDA applicant, unverified
- Devices
- 48
What Dfine, Inc. makes
Dfine, Inc. manufactures bone cement formulations, including SPACE CPSXL and STABILI ERX, as well as vertebral augmentation systems designed for use with these cements. The company also produces ablation instruments, such as the Model 1635 ablation instrument and the Model 1682 ablation multiplex catheter, alongside a delivery system for targeted medical procedures. Modifications to existing bone cement products are also part of the portfolio.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. These products are listed in the FDA’s 510(k) database. Dfine, Inc. is based in the United States.
Catalogue
Search and filter all 48 devicesCompany details
- DUNS number
- 169957607
Frequently asked questions
How many devices does Dfine, Inc. have in the registry?
The registry currently lists 48 devices for Dfine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dfine, Inc.'s devices?
Among its 48 most recently registered devices, Dfine, Inc. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (43 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Dfine, Inc.'s devices fall under?
Among its 48 most recently registered devices, the classes recorded for Dfine, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dfine, Inc. in the registry?
The most recently registered devices listed for Dfine, Inc. include StabiliT MX Fracture Kit MX-2100L-01, StabiliT VP Fracture Kit VP-0010A, StabiliT ER2 Bone Cement and Saturate Mixing System 1688 and StabiliT First Fracture Kit 3353.