Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Osseon, LLC — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straigh | Osseon, LLC | 2015-04-09 | 30 | 0 |
| K141930 | OSSEOFLEX SB, 10G/4ML, OSSEOFLEX SB, 10G/2ML | Osseon, LLC | 2014-08-21 | 36 | 0 |
| K140937 | OSSEOFLEX SB | Osseon, LLC | 2014-06-19 | 69 | 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