Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ortho-Pro, LLC — 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) |
|---|---|---|---|---|---|
| K102601 | ORTHOFLEX ROD | Ortho-Pro, LLC | 2011-01-14 | 127 | 0 |
| K094037 | TC PLATING SYSTEM | Ortho-Pro, LLC | 2010-03-10 | 70 | 0 |
| K042310 | ORTHO-PRO CANNULATED BONE SCREWS | Ortho-Pro, LLC | 2004-09-16 | 22 | 0 |
| K032682 | STS SCREW | Ortho-Pro, LLC | 2003-10-22 | 54 | 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