Neos Surgery S.L.
Cerdanyola del Vallès Barcelona, ES
NEOS SURGERY S.L. appears in FDA device records in Cerdanyola del Vallès Barcelona, ES. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Neos Surgery S.L. between 2010 and 2024. The busiest year on record is 2022, with 2. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2013 | 1 |
| 2016 | 1 |
| 2022 | 2 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | GXR | Substantially Equivalent | |
| K221795 | STERN FIX Sternal Stabilization System | JDQ | Substantially Equivalent | |
| K211613 | Stern Fix Sternal Stabilization System | JDQ | Substantially Equivalent | |
| K160739 | Cranial COVER | GXR | Substantially Equivalent | |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | GXR | Substantially Equivalent | |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | GXR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008974316 | 3008974316 | NEOS SURGERY S.L. | Parc Tecnològic del Vallès, Cerdanyola del Vallès Barcelona 08290 ES | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain