Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neos Surgery S.L · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
238 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bon | Neos Surgery S.L | 2024-02-16 | 29 | 0 |
| K221795 | STERN FIX Sternal Stabilization System | Neos Surgery S.L | 2022-10-19 | 120 | 0 |
| K211613 | Stern Fix Sternal Stabilization System | Neos Surgery S.L | 2022-01-19 | 238 | 0 |
| K160739 | Cranial COVER | Neos Surgery S.L | 2016-06-12 | 87 | 0 |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL | Neos Surgery S.L | 2013-09-30 | 90 | 0 |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | Neos Surgery S.L | 2010-10-25 | 175 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda