Spinevision, S.A.S.
FranceFDA applicant, unverified
- Devices
- 5
What Spinevision, S.A.S. makes
Spinevision, S.A.S. manufactures Hexanium spinal fixation systems, including anterior cervical interbody fusion (ACIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) implants designed for surgical use in spinal stabilization procedures.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hexanium® ACIF Ref K193000
Regimes: 510(k) Registry: 510(k)Hexanium ACIF Ref K221578
Regimes: 510(k) Registry: 510(k)Hexanium TLIF Ref K210359
Regimes: 510(k) Registry: 510(k)Hexanium PLIF Ref K223251
Regimes: 510(k) Registry: 510(k)Hexanium® TLIF Ref K180437
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Spinevision, S.A.S. have in the registry?
The registry currently lists 5 devices for Spinevision, S.A.S.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Spinevision, S.A.S.'s devices?
Among its 5 most recently registered devices, Spinevision, S.A.S. has devices listed in FDA 510(k) (5 devices).
What risk classes do Spinevision, S.A.S.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Spinevision, S.A.S.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Spinevision, S.A.S. in the registry?
The most recently registered devices listed for Spinevision, S.A.S. include Hexanium® ACIF, Hexanium ACIF, Hexanium TLIF and Hexanium PLIF.