Xtremi-T, LLC
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Xtremi-T, LLC makes
Xtremi-T, LLC manufactures biodegradable fixation devices, including REFIX PIN implants made from PLLA and PLGA polymers in multiple sizes (models 2070L, 2770L, 3570L, 4570L and corresponding LG variants), as well as REFIX internal fracture fixation screws.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
Refix Pin (Plla), Models 2070l, 2770l, 3570l, 4570l; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG Ref K043339
510(k) 510(k)Refix Internal Fracture Fixation Screws Ref K050388
510(k) 510(k)
Frequently asked questions
How many devices does Xtremi-T, LLC have in the registry?
The registry currently lists 2 devices for Xtremi-T, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Xtremi-T, LLC's devices?
Among its 2 most recently registered devices, Xtremi-T, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Xtremi-T, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Xtremi-T, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Xtremi-T, LLC in the registry?
The most recently registered devices listed for Xtremi-T, LLC include REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG and REFIX INTERNAL FRACTURE FIXATION SCREWS.