Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ossdsign AB — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
220 daysmedian FDA review time
276 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232315 | Catalyst Bone Void Filler | Ossdsign AB | 2023-09-15 | 44 | 0 |
| K212414 | OSSDSIGN Cranial PSI | Ossdsign AB | 2021-10-01 | 59 | 0 |
| K190523 | Cranial PSI Accessory – Anatomical Model Original, Cranial P | Ossdsign AB | 2019-10-10 | 220 | 0 |
| K181539 | OSSDSIGN Cranioplug | Ossdsign AB | 2018-10-12 | 123 | 0 |
| K161090 | Cranial PSI | Ossdsign AB | 2017-01-19 | 276 | 0 |
| K140309 | CRANIOPLUG | Ossdsign AB | 2014-10-03 | 238 | 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