Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Quantum Orthopedics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
198 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062004 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2006-08-15 | 29 | 0 |
| K061576 | MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM | Quantum Orthopedics, Inc. | 2006-07-03 | 26 | 0 |
| K052641 | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2006-04-12 | 198 | 0 |
| K060491 | QUANTUM ANTERIOR CERVICAL PLATE SYSTEM | Quantum Orthopedics, Inc. | 2006-03-13 | 17 | 0 |
| K050449 | QUANTUM VERTEBRAL BODY REPLACEMENT | Quantum Orthopedics, Inc. | 2005-07-07 | 135 | 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