Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthopedic Alliance, 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) |
|---|---|---|---|---|---|
| K052237 | SC CERAMIC BALL HEADS | Orthopedic Alliance, LLC | 2005-09-06 | 20 | 0 |
| K033826 | ORTHOPEDIC ALLIANCE SPINE SYSTEM | Orthopedic Alliance, LLC | 2004-07-01 | 204 | 1 |
| K031474 | SC TOTAL HIP SYSTEM | Orthopedic Alliance, LLC | 2003-10-15 | 159 | 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