Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magly Orthopedics, 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) |
|---|---|---|---|---|---|
| K021662 | MAGLY 6.5MM CANNULATED SCREWS | Magly Orthopedics, LLC | 2002-08-12 | 84 | 0 |
| K021579 | MAGLY 4.0 AND 5.5 MM LOCKING SYSTEM | Magly Orthopedics, LLC | 2002-08-09 | 87 | 0 |
| K020562 | APEX INTRAMEDULLARY NAIL SYSTEM | Magly Orthopedics, LLC | 2002-05-16 | 85 | 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