NEOORTHO
Model 911.366 · Neoortho Produtos Ortopédicos S/A. · DI 07899893216000
HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030
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 | 1.6 |
| 2019-02 | 0 | 1.4 |
| 2019-03 | 0 | 2.25 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 0 | 2.33 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1.33 |
| 2019-09 | 0 | 1.83 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 2.5 |
| 2020-02 | 0 | 3.18 |
| 2020-03 | 0 | 1.4 |
| 2020-04 | 0 | 2.6 |
| 2020-05 | 0 | 3.13 |
| 2020-06 | 0 | 3.25 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 3 |
| 2020-09 | 0 | 4.64 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 2.33 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 2.22 |
| 2021-02 | 0 | 2.91 |
| 2021-03 | 0 | 2.22 |
| 2021-04 | 0 | 2.56 |
| 2021-05 | 0 | 2.14 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 1.8 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 2.45 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 2.92 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 3.2 |
| 2022-02 | 0 | 2.67 |
| 2022-03 | 0 | 2.6 |
| 2022-04 | 0 | 3.42 |
| 2022-05 | 0 | 2.14 |
| 2022-06 | 0 | 1.67 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 4.9 |
| 2022-09 | 0 | 2.2 |
| 2022-10 | 0 | 1.57 |
| 2022-11 | 0 | 3.25 |
| 2022-12 | 0 | 3.67 |
| 2023-01 | 0 | 2.5 |
| 2023-02 | 0 | 3 |
| 2023-03 | 0 | 2.88 |
| 2023-04 | 0 | 3.25 |
| 2023-05 | 0 | 3.67 |
| 2023-06 | 0 | 2.57 |
| 2023-07 | 0 | 1.8 |
| 2023-08 | 0 | 3.29 |
| 2023-09 | 0 | 1.67 |
| 2023-10 | 0 | 2.5 |
| 2023-11 | 0 | 3.33 |
| 2023-12 | 0 | 4.38 |
| 2024-01 | 0 | 3.92 |
| 2024-02 | 0 | 3.35 |
| 2024-03 | 0 | 2.92 |
| 2024-04 | 0 | 3.44 |
| 2024-05 | 0 | 4.87 |
| 2024-06 | 0 | 6.31 |
| 2024-07 | 0 | 3.73 |
| 2024-08 | 0 | 1.93 |
| 2024-09 | 0 | 2.85 |
| 2024-10 | 0 | 2.63 |
| 2024-11 | 0 | 2.5 |
| 2024-12 | 0 | 1.86 |
| 2025-01 | 0 | 3.5 |
| 2025-02 | 0 | 3.87 |
| 2025-03 | 0 | 3 |
| 2025-04 | 0 | 2.82 |
| 2025-05 | 0 | 5.6 |
| 2025-06 | 0 | 1.53 |
| 2025-07 | 0 | 3.42 |
| 2025-08 | 0 | 2.58 |
| 2025-09 | 0 | 2.27 |
| 2025-10 | 0 | 3.08 |
| 2025-11 | 0 | 2.42 |
| 2025-12 | 0 | 2.13 |
| 2026-01 | 0 | 2.7 |
| 2026-02 | 0 | 1.89 |
| 2026-03 | 0 | 3 |
| 2026-04 | 0 | 2.91 |
| 2026-05 | 0 | 3.25 |
| 2026-06 | 0 | 2.82 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K162874 — cites (transitively): K050636 (d1), K142057 (d1), K012945 (d2), K021932 (d2), K111678 (d2), K962011 (d2), K962823 (d2), K963172 (d2), K963192 (d2), K043059 (d3), K060746 (d3), K070031 (d3), K082320 (d3), K963118 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Neoortho Produtos Ortopédicos S/A.
Nothing in the loaded window.