Neos Surgery S.L
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Neos Surgery S.L makes
Neos Surgery S.L. manufactures cranial bone fixation systems, including the Cranial Loop (standard, L, and XL variants) and the Cranial Cover, as well as sternal stabilization devices like the Stern Fix system. These products are designed for orthopedic and reconstructive applications in cranial and sternal surgeries.
The company’s devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) registry. The portfolio is authorised for use in the United States, where the manufacturer is based.
Catalogue
- 510(k) 510(k)
Cranial Loop Cranial Bone Fixation System Ref K101235
510(k) 510(k)- 510(k) 510(k)
STERN FIX Sternal Stabilization System Ref K221795
510(k) 510(k)Cranial COVER Ref K160739
510(k) 510(k)Stern Fix Sternal Stabilization System Ref K211613
510(k) 510(k)
FDA establishments
- Neos Surgery S.L. Cerdanyola del Vallès Barcelona · ES FEI 3008974316
Frequently asked questions
How many devices does Neos Surgery S.L have in the registry?
The registry currently lists 6 devices for Neos Surgery S.L. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neos Surgery S.L's devices?
Among its 6 most recently registered devices, Neos Surgery S.L has devices listed in FDA 510(k) (6 devices).
What risk classes do Neos Surgery S.L's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Neos Surgery S.L's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neos Surgery S.L in the registry?
The most recently registered devices listed for Neos Surgery S.L include CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM, CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM, Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System and STERN FIX Sternal Stabilization System.
Which FDA establishments are linked to Neos Surgery S.L?
1 FDA establishment is linked to Neos Surgery S.L in the registry; they are listed on the company page.