Sciences ET Bio Materiaux (Sbm)
FranceFDA applicant, unverified
- Devices
- 2
What Sciences ET Bio Materiaux (Sbm) makes
Sciences ET Bio Materiaux (Sbm) manufactures the OTIS-C PLUS, a medical device for orthopedic applications, and BIOSORB, a resorbable void filler used in bone reconstruction or defect management. These products are designed to support surgical procedures requiring structural support or tissue integration.
The company’s portfolio is regulated under FDA Class II devices, with authorisation via the 510(k) pathway. The devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Otis -C Plus Ref K100604
Regimes: 510(k) Registry: 510(k)Biosorb Resorbable Void Filler Ref K021963
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sciences ET Bio Materiaux (Sbm) have in the registry?
The registry currently lists 2 devices for Sciences ET Bio Materiaux (Sbm). Devices recorded under merged duplicate company entries are counted once.
Which registries list Sciences ET Bio Materiaux (Sbm)'s devices?
Among its 2 most recently registered devices, Sciences ET Bio Materiaux (Sbm) has devices listed in FDA 510(k) (2 devices).
What risk classes do Sciences ET Bio Materiaux (Sbm)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Sciences ET Bio Materiaux (Sbm)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sciences ET Bio Materiaux (Sbm) in the registry?
The most recently registered devices listed for Sciences ET Bio Materiaux (Sbm) include OTIS -C PLUS and BIOSORB RESORBABLE VOID FILLER.