ArgenIs
Model NR 3.5 Final Screw · ARGEN CORPORATION, THE · DI D818120067
DZL — Screw, Fixation, Intraosseous · Class II · 21 CFR 872.4880
UDILibrary device dossier · generated 2026-09-11 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1.33 |
| 2019-03 | 0 | 1.63 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 2.25 |
| 2019-12 | 0 | 1.4 |
| 2020-01 | 0 | 1.7 |
| 2020-02 | 0 | 1.5 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 2 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 2.29 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1.43 |
| 2021-01 | 0 | 2.5 |
| 2021-02 | 0 | 2.5 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2.8 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 3 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1.67 |
| 2021-09 | 0 | 1.5 |
| 2021-10 | 0 | 1.25 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 2.75 |
| 2022-01 | 0 | 3 |
| 2022-02 | 0 | 1.5 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 2.5 |
| 2022-05 | 0 | 15.33 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 4 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 7.83 |
| 2022-11 | 0 | 3.33 |
| 2022-12 | 0 | 7.35 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 8.88 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.5 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 2.75 |
| 2023-10 | 0 | 1.14 |
| 2023-11 | 0 | 1.33 |
| 2023-12 | 0 | 3.5 |
| 2024-01 | 0 | 5 |
| 2024-02 | 0 | 2.5 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 3.33 |
| 2024-10 | 0 | 1.17 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 2.4 |
| 2025-02 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 2.5 |
| 2025-07 | 0 | 1.33 |
| 2025-08 | 0 | 2.33 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1.67 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1.4 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1.67 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K143051 — cites (transitively): K062566 (d1), K081419 (d1), K083192 (d1), K130183 (d1), K130949 (d1), K132814 (d1), K133339 (d1), K083876 (d2), K102382 (d2), K101977 (d2), K111889 (d2), K070007 (d3) — cited as predicate by K160248, K173701
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — ARGEN CORPORATION, THE
- VAI 2013-12-12 Argen Corporation, The · 5 citations