SITTER 3.5mm Versatile Plate, 19 Hole
Model B-240400 · Bonebridge AG · DI 07640187462340
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-13 · 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 | 1.94 |
| 2019-02 | 0 | 1.56 |
| 2019-03 | 0 | 1.88 |
| 2019-04 | 0 | 2.36 |
| 2019-05 | 0 | 1.69 |
| 2019-06 | 0 | 1.64 |
| 2019-07 | 0 | 1.68 |
| 2019-08 | 0 | 1.54 |
| 2019-09 | 0 | 1.66 |
| 2019-10 | 0 | 1.53 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 2.19 |
| 2020-02 | 0 | 1.28 |
| 2020-03 | 0 | 1.64 |
| 2020-04 | 0 | 1.95 |
| 2020-05 | 0 | 1.79 |
| 2020-06 | 0 | 1.92 |
| 2020-07 | 0 | 1.93 |
| 2020-08 | 0 | 2.34 |
| 2020-09 | 0 | 2.75 |
| 2020-10 | 0 | 1.95 |
| 2020-11 | 0 | 2.34 |
| 2020-12 | 0 | 2.26 |
| 2021-01 | 0 | 1.79 |
| 2021-02 | 0 | 1.94 |
| 2021-03 | 0 | 2.13 |
| 2021-04 | 0 | 2.85 |
| 2021-05 | 0 | 2.64 |
| 2021-06 | 0 | 2.05 |
| 2021-07 | 0 | 2.28 |
| 2021-08 | 0 | 1.87 |
| 2021-09 | 0 | 2.04 |
| 2021-10 | 0 | 2.02 |
| 2021-11 | 0 | 2.05 |
| 2021-12 | 0 | 2.21 |
| 2022-01 | 0 | 2.88 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 1.65 |
| 2022-04 | 0 | 2.04 |
| 2022-05 | 0 | 1.96 |
| 2022-06 | 0 | 2.35 |
| 2022-07 | 0 | 2.26 |
| 2022-08 | 0 | 2.01 |
| 2022-09 | 0 | 2.39 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 2.93 |
| 2022-12 | 0 | 2.83 |
| 2023-01 | 0 | 2.51 |
| 2023-02 | 0 | 2.57 |
| 2023-03 | 0 | 2.98 |
| 2023-04 | 0 | 3.11 |
| 2023-05 | 0 | 4.19 |
| 2023-06 | 0 | 2.96 |
| 2023-07 | 0 | 2.23 |
| 2023-08 | 0 | 2.22 |
| 2023-09 | 0 | 2.08 |
| 2023-10 | 0 | 2.45 |
| 2023-11 | 0 | 2.03 |
| 2023-12 | 0 | 2.42 |
| 2024-01 | 0 | 2.06 |
| 2024-02 | 0 | 1.72 |
| 2024-03 | 0 | 1.82 |
| 2024-04 | 0 | 2.09 |
| 2024-05 | 0 | 1.95 |
| 2024-06 | 0 | 2.35 |
| 2024-07 | 0 | 2.23 |
| 2024-08 | 0 | 2.28 |
| 2024-09 | 0 | 1.66 |
| 2024-10 | 0 | 2.32 |
| 2024-11 | 0 | 1.61 |
| 2024-12 | 0 | 2.88 |
| 2025-01 | 0 | 1.62 |
| 2025-02 | 0 | 1.76 |
| 2025-03 | 0 | 2.68 |
| 2025-04 | 0 | 1.82 |
| 2025-05 | 0 | 2.08 |
| 2025-06 | 0 | 1.73 |
| 2025-07 | 0 | 2.09 |
| 2025-08 | 0 | 2.1 |
| 2025-09 | 0 | 1.75 |
| 2025-10 | 0 | 2.08 |
| 2025-11 | 0 | 1.92 |
| 2025-12 | 0 | 2.46 |
| 2026-01 | 0 | 1.7 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 3.1 |
| 2026-04 | 0 | 2.2 |
| 2026-05 | 0 | 2.03 |
| 2026-06 | 0 | 1.84 |
Regulatory clearances
- K240318 SESE 2024-08-23 (k number procode)
Predicate lineage
K240318 — cites (transitively): K082807 (d1), K231292 (d1), K011815 (d2), K041860 (d2), K101056 (d2), K120070 (d2), K120689 (d2), K213864 (d2), K073527 (d3), K000682 (d3), K052390 (d3), K083286 (d3), K051567 (d3), K073186 (d3), K082624 (d3), K092247 (d3), K111540 (d3), K142906 (d3), K203002 (d3), K000684 (d4), K040022 (d4), K070946 (d4), K103332 (d4), K011335 (d4), K033805 (d5), K063049 (d5), K092038 (d5) — cited as predicate by K242399, K243308
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Bonebridge AG
Nothing in the loaded window.