Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Ht Medical D.B.A. Xenix Medical · 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) |
|---|---|---|---|---|---|
| K251154 | RIVA Posterior Fixation System; RIVA Posterior Fixation Syst | Ht Medical D.B.A. Xenix Medical | 2025-06-12 | 59 | 0 |
| K222988 | neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cer | Ht Medical D.B.A. Xenix Medical | 2023-09-01 | 338 | 0 |
| K231829 | Xenix Medical Sacroiliac Fixation System | Ht Medical D.B.A. Xenix Medical | 2023-08-15 | 55 | 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