Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nvision Biomedical Technologies, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
263 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253718 | enHAnce PEEK Bunion System | Nvision Biomedical Technologies, Inc. | 2026-04-01 | 128 | 0 |
| K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026-03-25 | 55 | 0 |
| K253423 | ToeJack MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2025-11-18 | 54 | 0 |
| K252657 | Impact PEEK Union Nail System | Nvision Biomedical Technologies, Inc. | 2025-09-19 | 28 | 0 |
| K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025-04-02 | 33 | 0 |
| K240250 | 3D Printed PEEK Interbody System | Nvision Biomedical Technologies, Inc. | 2024-09-17 | 231 | 0 |
| K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024-02-16 | 274 | 0 |
| K230853 | EARP Nerve Cuff Electrode | Nvision Biomedical Technologies, Inc. | 2023-10-06 | 192 | 0 |
| K222015 | Integral Titanium Cervical Interbody | Nvision Biomedical Technologies, Inc. | 2023-07-05 | 362 | 0 |
| K223226 | Trigon™ HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-12-01 | 44 | 0 |
| K212477 | EARP Interbody System | Nvision Biomedical Technologies, Inc. | 2022-04-28 | 262 | 0 |
| K220197 | Trigon HA Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2022-02-23 | 30 | 0 |
| K211650 | The Radian MIS Bunion System | Nvision Biomedical Technologies, Inc. | 2021-11-24 | 180 | 0 |
| K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021-11-19 | 30 | 0 |
| K210424 | Quantum Anterior Cervical Plate | Nvision Biomedical Technologies, Inc. | 2021-10-22 | 253 | 0 |
| K203445 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-21 | 28 | 0 |
| K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020-12-14 | 91 | 0 |
| K200428 | Multi-Drive Interference Screw System | Nvision Biomedical Technologies, Inc. | 2020-11-10 | 263 | 0 |
| K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020-08-04 | 29 | 0 |
| K200914 | Healix Compression Screw System | Nvision Biomedical Technologies, Inc. | 2020-05-05 | 29 | 0 |
| K193414 | Trigon HA Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2020-02-25 | 78 | 0 |
| K193645 | nva, nvp, and nvt | Nvision Biomedical Technologies, Inc. | 2020-01-13 | 14 | 0 |
| K192645 | Trigon™ Ti Stand-Alone Wedge Fixation System | Nvision Biomedical Technologies, Inc. | 2019-12-23 | 90 | 0 |
| K190380 | nvc | Nvision Biomedical Technologies, Inc. | 2019-03-21 | 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