MOUNTAINEER
Model 188328318 · Medos International Sàrl · DI 10705034158570
KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050
MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070
MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070
NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075
UDILibrary device dossier · generated 2026-09-12 · 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 | 2.08 |
| 2019-02 | 0 | 1.9 |
| 2019-03 | 0 | 1.98 |
| 2019-04 | 0 | 2.03 |
| 2019-05 | 0 | 2.23 |
| 2019-06 | 0 | 2.54 |
| 2019-07 | 0 | 1.66 |
| 2019-08 | 0 | 2.71 |
| 2019-09 | 0 | 1.78 |
| 2019-10 | 0 | 1.83 |
| 2019-11 | 0 | 2.17 |
| 2019-12 | 0 | 1.64 |
| 2020-01 | 0 | 2.5 |
| 2020-02 | 0 | 2.3 |
| 2020-03 | 0 | 2.25 |
| 2020-04 | 0 | 1.56 |
| 2020-05 | 0 | 2.21 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 1.75 |
| 2020-08 | 0 | 1.86 |
| 2020-09 | 0 | 2.31 |
| 2020-10 | 0 | 2.46 |
| 2020-11 | 0 | 2.28 |
| 2020-12 | 0 | 2.06 |
| 2021-01 | 0 | 2.17 |
| 2021-02 | 0 | 1.89 |
| 2021-03 | 0 | 2.37 |
| 2021-04 | 0 | 2.19 |
| 2021-05 | 0 | 1.98 |
| 2021-06 | 0 | 1.82 |
| 2021-07 | 0 | 7.94 |
| 2021-08 | 0 | 1.96 |
| 2021-09 | 0 | 1.7 |
| 2021-10 | 0 | 2.5 |
| 2021-11 | 0 | 2.15 |
| 2021-12 | 0 | 2.19 |
| 2022-01 | 0 | 2.1 |
| 2022-02 | 0 | 1.89 |
| 2022-03 | 0 | 1.83 |
| 2022-04 | 0 | 1.95 |
| 2022-05 | 0 | 1.75 |
| 2022-06 | 0 | 2.02 |
| 2022-07 | 0 | 3.46 |
| 2022-08 | 0 | 1.97 |
| 2022-09 | 0 | 2.78 |
| 2022-10 | 0 | 1.44 |
| 2022-11 | 0 | 1.89 |
| 2022-12 | 0 | 2.01 |
| 2023-01 | 0 | 1.69 |
| 2023-02 | 0 | 1.83 |
| 2023-03 | 0 | 1.93 |
| 2023-04 | 0 | 2.02 |
| 2023-05 | 0 | 1.74 |
| 2023-06 | 0 | 1.72 |
| 2023-07 | 0 | 1.86 |
| 2023-08 | 0 | 1.48 |
| 2023-09 | 0 | 2.78 |
| 2023-10 | 0 | 2.64 |
| 2023-11 | 0 | 2.49 |
| 2023-12 | 0 | 1.62 |
| 2024-01 | 0 | 2.46 |
| 2024-02 | 0 | 2.12 |
| 2024-03 | 0 | 3.82 |
| 2024-04 | 0 | 1.76 |
| 2024-05 | 0 | 3.37 |
| 2024-06 | 0 | 1.91 |
| 2024-07 | 0 | 1.9 |
| 2024-08 | 0 | 2 |
| 2024-09 | 0 | 2.21 |
| 2024-10 | 0 | 2.07 |
| 2024-11 | 0 | 2.17 |
| 2024-12 | 0 | 1.75 |
| 2025-01 | 0 | 2.28 |
| 2025-02 | 0 | 2.39 |
| 2025-03 | 0 | 2.3 |
| 2025-04 | 0 | 2.29 |
| 2025-05 | 0 | 2.12 |
| 2025-06 | 0 | 2.25 |
| 2025-07 | 0 | 2.07 |
| 2025-08 | 0 | 1.87 |
| 2025-09 | 0 | 1.92 |
| 2025-10 | 0 | 2.04 |
| 2025-11 | 0 | 1.95 |
| 2025-12 | 0 | 2.23 |
| 2026-01 | 0 | 2.54 |
| 2026-02 | 0 | 2.44 |
| 2026-03 | 0 | 2.56 |
| 2026-04 | 0 | 1.82 |
| 2026-05 | 0 | 1.99 |
| 2026-06 | 0 | 4.63 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K080828 — cited as predicate by K093319, K103100, K110353, K132332, K151224, K181350
K151885 — cites (transitively): K042508 (d1), K132332 (d1), K142838 (d1), K041203 (d2), K080828 (d2), K110353 (d2), K062254 (d2) — cited as predicate by K150474, K153370, K161498, K172139, K181350, K181949, K190895, K192013, K192646, K200571, K203319
K190895 — cites (transitively): K151885 (d1), K181949 (d1), K963350 (d1), K980368 (d1), K982483 (d1), K042508 (d2), K132332 (d2), K142838 (d2), K041203 (d3), K080828 (d3), K110353 (d3), K062254 (d3) — cited as predicate by K192014, K192646, K200936, K203319, K253195
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl
Nothing in the loaded window.