Medtech S.A
FranceFDA applicant, unverified
- Devices
- 8
What Medtech S.A makes
Medtech S.A manufactures robotic-assisted surgical systems, including the ROSA ONE platform for spine and brain applications, as well as standalone ROSA Brain and ROSA Spine devices. These tools are designed for computer-guided neurosurgical and orthopedic procedures, providing real-time imaging and navigation support during surgery.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
ROSA ONE Spine application Ref K192173
Regimes: 510(k) Registry: 510(k)ROSA BRAIN (v3.0.0.5) Ref K172444
Regimes: 510(k) Registry: 510(k)Rosa Surgical Device, Model Rosa 1.1 Ref K092239
Regimes: 510(k) Registry: 510(k)ROSA Brain Ref K151359
Regimes: 510(k) Registry: 510(k)ROSA Spine Ref K151511
Regimes: 510(k) Registry: 510(k)ROSA ONE Spine application Ref K182848
Regimes: 510(k) Registry: 510(k)ROSA ONE Brain Application Ref K182417
Regimes: 510(k) Registry: 510(k)ROSA ONE Brain application Ref K200511
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtech S.A have in the registry?
The registry currently lists 8 devices for Medtech S.A. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtech S.A's devices?
Among its 8 most recently registered devices, Medtech S.A has devices listed in FDA 510(k) (8 devices).
What risk classes do Medtech S.A's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Medtech S.A's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtech S.A in the registry?
The most recently registered devices listed for Medtech S.A include ROSA ONE Spine application, ROSA BRAIN (v3.0.0.5), ROSA SURGICAL DEVICE, MODEL ROSA 1.1 and ROSA Brain.