Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nvision Biomedical Technologies — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250646 | Impact PEEK Union Nail System | Nvision Biomedical Technologies | 2025-06-11 | 99 | 0 |
| K242896 | Caliber Intramedullary Fixation System | Nvision Biomedical Technologies | 2025-02-05 | 135 | 0 |
| K243231 | Trigon PEEK HA Wedges | Nvision Biomedical Technologies | 2024-11-08 | 30 | 0 |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies | 2024-01-26 | 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