Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medicrea International S.A.S. (Medtronic) · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261289 | UNiD™ Spine Analyzer (SW3002) | Medicrea International S.A.S. (Medtronic) | 2026-05-15 | 25 | 0 |
| K253577 | IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant I | Medicrea International S.A.S. (Medtronic) | 2025-12-19 | 32 | 0 |
| K251629 | UNiD™ Spine Analyzer | Medicrea International S.A.S. (Medtronic) | 2025-08-07 | 71 | 0 |
| K241164 | IB3D™ PL Spinal System | Medicrea International S.A.S. (Medtronic) | 2024-09-06 | 133 | 2 |
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