Data / Medical devices / Spain / Neos Surgery S.L.
Neos Surgery S.L.: FDA-registered device maker in Cerdanyola del Vallès Barcelona, Spain, 3 510(k) clearances
Neos Surgery S.L. is registered with the FDA (registration 3008974316) in Cerdanyola del Vallès Barcelona, Spain. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008974316
- Address
- Parc Tecnològic del Vallès C/Ceramistes, 2, Cerdanyola del Vallès Barcelona, Spain, 08290
- Owner or operator
- Neos Surgery S.L. (10036243)
- Roles
- Manufacturer
- First device listed
- October 21, 2013
- Registered through
- 2026
- Brand names listed
- Cranial COVER, Cranial Loop - Cranial Bone Fixation System, SCI0000- Depth gauge, SCI0300- Retractor, SCI0501- Forceps, SCI0700- Cutter_ Kerrison, STERN FIX Sternal Stabilization System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cerclage, Fixation | JDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cover, Burr Hole | GXR | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 19, 2022 | K221795 | STERN FIX Sternal Stabilization System | JDQ | Substantially Equivalent | Neos Surgery S.L | accessdata.fda.gov |
| June 12, 2016 | K160739 | Cranial COVER | GXR | Substantially Equivalent | Neos Surgery S.L | accessdata.fda.gov |
| September 30, 2013 | K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | GXR | Substantially Equivalent | Neos Surgery S.L | accessdata.fda.gov |
Compare with other makers
- All makers of Orthopedic Manual Surgical Instrument
- All makers of Cover, Burr Hole
- All makers of Cerclage, Fixation
Updated October 19, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.