Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Oral Osteodistraction, L.P. · 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) |
|---|---|---|---|---|---|
| K042278 | ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5) | Oral Osteodistraction, L.P. | 2005-01-28 | 158 | 0 |
| K034045 | ORAL OSTEODISTRACTION DISTRACTION ROD APPLIANCES, ROD 4 | Oral Osteodistraction, L.P. | 2004-03-23 | 85 | 0 |
| K014001 | DISTRACTION OSTEOGENESIS ROD APPLIANCES, MODELS 1, 2, AND 3 | Oral Osteodistraction, L.P. | 2003-02-04 | 427 | 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