Scandius Biomedical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Scandius Biomedical, Inc. makes
Scandius Biomedical, Inc. manufactures absorbable and non-absorbable anterior cruciate ligament (ACL) reconstruction systems, including tibial and combined tibial-femoral fixation devices. Their portfolio includes modular reconstruction kits designed for knee surgery, featuring both permanent and resorbable components for graft fixation.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Scandius Acl Reconstruction System Ref K041749
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Scandius Tritis Tibial Acl Reconstruction System Ref K052810
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Scandius Absorbable Acl Reconstruction System Ref K041961
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scandius Biomedical, Inc. have in the registry?
The registry currently lists 6 devices for Scandius Biomedical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scandius Biomedical, Inc.'s devices?
Among its 6 most recently registered devices, Scandius Biomedical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Scandius Biomedical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Scandius Biomedical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scandius Biomedical, Inc. in the registry?
The most recently registered devices listed for Scandius Biomedical, Inc. include SCANDIUS ACL RECONSTRUCTION SYSTEM, SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM, SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM and MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM.