Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fin-Ceramica Faenza S.P.A. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
278 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240567 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2024-03-28 | 28 | 0 |
| K193547 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2020-01-17 | 28 | 0 |
| K180513 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2018-05-15 | 77 | 0 |
| K171507 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2017-09-01 | 101 | 0 |
| K160707 | CustomizedBone Service | Fin-Ceramica Faenza S.P.A. | 2016-12-17 | 278 | 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