Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bacterin International, Inc. · 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) |
|---|---|---|---|---|---|
| K150621 | OsteoSelect PLUS Demineralized Bone Matrix Putty | Bacterin International, Inc. | 2015-08-18 | 160 | 0 |
| K130498 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2013-05-31 | 94 | 0 |
| K091321 | OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY | Bacterin International, Inc. | 2009-09-11 | 129 | 2 |
| K063245 | ELUTIA COATED CLOSED SURGICAL WOUND DRAIN | Bacterin International, Inc. | 2007-11-28 | 398 | 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