Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remex Medical Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
30 daysmedian FDA review time
182 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251315 | Anatase Spine Surgery Navigation System and Remex Spine Surg | Remex Medical Corp. | 2025-05-29 | 30 | 0 |
| K243560 | Remex Spine Surgery Navigation Instrument | Remex Medical Corp. | 2024-12-13 | 25 | 0 |
| K241625 | Anatase Navi Disposable Instrument | Remex Medical Corp. | 2024-07-05 | 29 | 0 |
| K233513 | Remex Spine Surgery Navigation System II | Remex Medical Corp. | 2024-05-01 | 182 | 0 |
| K230783 | Anatase Spine Surgery Navigation System | Remex Medical Corp. | 2023-04-21 | 30 | 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