Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neo Medical SA · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
285 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243693 | NEO Pedicle Screw System™ | Neo Medical SA | 2024-12-23 | 24 | 0 |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System™ | Neo Medical SA | 2022-08-26 | 30 | 0 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | Neo Medical SA | 2021-10-28 | 80 | 0 |
| K191796 | Neo Cage System | Neo Medical SA | 2019-12-13 | 163 | 0 |
| K181048 | Neo Cage System TM | Neo Medical SA | 2019-01-29 | 285 | 0 |
| K171582 | NEO Pedicle Screw System™ | Neo Medical SA | 2017-09-12 | 104 | 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