Bioloren S.r.l.
ItalyFDA applicant, unverified
- Devices
- 3
What Bioloren S.r.l. makes
Bioloren S.R.L. manufactures orthopedic implants, including Trilor Disks, Blocks, and Arches, as well as Fiber Disk and Block variants, such as the permanent Trinia model. These products are designed for spinal and joint stabilization procedures, providing structural support during surgical interventions.
The company’s portfolio is classified under FDA Class II devices and is listed in the 510(k) registry. The products are regulated under US medical device laws, ensuring compliance with FDA requirements for safety and performance. Bioloren S.R.L. operates from the United States.
Catalogue
Trilor Disks, Blocks and Arches Ref K173643
Regimes: 510(k) Registry: 510(k)Fiber Disk And Block Ref K112186
Regimes: 510(k) Registry: 510(k)Fiber Disk And Block Permanent, Trinia Ref K121735
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioloren S.R.L. have in the registry?
The registry currently lists 3 devices for Bioloren S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioloren S.R.L.'s devices?
Among its 3 most recently registered devices, Bioloren S.R.L. has devices listed in FDA 510(k) (3 devices).
What risk classes do Bioloren S.R.L.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Bioloren S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioloren S.R.L. in the registry?
The most recently registered devices listed for Bioloren S.R.L. include Trilor Disks, Blocks and Arches, FIBER DISK AND BLOCK and FIBER DISK AND BLOCK PERMANENT, TRINIA.