Medicrea International S.A.S. (Medtronic)
FranceFDA applicant, unverified
- Devices
- 4
What Medicrea International S.A.S. (Medtronic) makes
Medicrea International S.A.S. manufactures software-based spinal analysis tools, including the UNiD Spine Analyzer for preoperative planning and imaging assessment, as well as hardware-assisted spinal implant systems like the IB3D PL Spinal System and its associated inserter tools for surgical precision.
The company’s products fall under Class II medical device classifications and are listed with the FDA via 510(k) clearance. The portfolio is regulated under European Union standards, and the manufacturer is based in France.
Catalogue
UNiD™ Spine Analyzer (SW3002) Ref K261289
Regimes: 510(k) Registry: 510(k)UNiD™ Spine Analyzer Ref K251629
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
IB3D™ PL Spinal System Ref K241164
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medicrea International S.A.S. (Medtronic) have in the registry?
The registry currently lists 4 devices for Medicrea International S.A.S. (Medtronic). Devices recorded under merged duplicate company entries are counted once.
Which registries list Medicrea International S.A.S. (Medtronic)'s devices?
Among its 4 most recently registered devices, Medicrea International S.A.S. (Medtronic) has devices listed in FDA 510(k) (4 devices).
What risk classes do Medicrea International S.A.S. (Medtronic)'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medicrea International S.A.S. (Medtronic)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medicrea International S.A.S. (Medtronic) in the registry?
The most recently registered devices listed for Medicrea International S.A.S. (Medtronic) include UNiD™ Spine Analyzer (SW3002), UNiD™ Spine Analyzer, IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) and IB3D™ PL Spinal System.