10.5 Arm Guide KIT
Model KIT1490-01 · MAZOR ROBOTICS LTD · DI 07290115750058
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 | 2.97 |
| 2019-02 | 0 | 4.45 |
| 2019-03 | 0 | 3.6 |
| 2019-04 | 0 | 3.18 |
| 2019-05 | 0 | 3.94 |
| 2019-06 | 0 | 3.31 |
| 2019-07 | 0 | 3.93 |
| 2019-08 | 0 | 4.29 |
| 2019-09 | 0 | 3.48 |
| 2019-10 | 0 | 4.12 |
| 2019-11 | 0 | 5.93 |
| 2019-12 | 0 | 4.32 |
| 2020-01 | 0 | 3.49 |
| 2020-02 | 0 | 5.16 |
| 2020-03 | 0 | 5.07 |
| 2020-04 | 0 | 8.75 |
| 2020-05 | 0 | 3.12 |
| 2020-06 | 0 | 3.41 |
| 2020-07 | 0 | 3.89 |
| 2020-08 | 0 | 2.74 |
| 2020-09 | 0 | 3.53 |
| 2020-10 | 0 | 5.36 |
| 2020-11 | 0 | 5.25 |
| 2020-12 | 0 | 4.21 |
| 2021-01 | 0 | 4.44 |
| 2021-02 | 0 | 3.93 |
| 2021-03 | 0 | 3.77 |
| 2021-04 | 0 | 3.78 |
| 2021-05 | 0 | 4.14 |
| 2021-06 | 0 | 3.67 |
| 2021-07 | 0 | 3.44 |
| 2021-08 | 0 | 3.19 |
| 2021-09 | 0 | 2.86 |
| 2021-10 | 0 | 2.49 |
| 2021-11 | 0 | 4.1 |
| 2021-12 | 0 | 2.91 |
| 2022-01 | 0 | 2.63 |
| 2022-02 | 0 | 3.08 |
| 2022-03 | 0 | 3.38 |
| 2022-04 | 0 | 2.42 |
| 2022-05 | 0 | 3.69 |
| 2022-06 | 0 | 4.19 |
| 2022-07 | 0 | 3.23 |
| 2022-08 | 0 | 2.87 |
| 2022-09 | 0 | 2.38 |
| 2022-10 | 0 | 3.7 |
| 2022-11 | 0 | 3.21 |
| 2022-12 | 0 | 3.77 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 3.25 |
| 2023-03 | 0 | 3.54 |
| 2023-04 | 0 | 2.97 |
| 2023-05 | 0 | 2.69 |
| 2023-06 | 0 | 2.64 |
| 2023-07 | 0 | 2.7 |
| 2023-08 | 0 | 2.45 |
| 2023-09 | 0 | 3.51 |
| 2023-10 | 0 | 3.27 |
| 2023-11 | 0 | 7.38 |
| 2023-12 | 0 | 3.52 |
| 2024-01 | 0 | 3.38 |
| 2024-02 | 0 | 3.89 |
| 2024-03 | 0 | 3.91 |
| 2024-04 | 0 | 4.13 |
| 2024-05 | 0 | 4.2 |
| 2024-06 | 0 | 3.92 |
| 2024-07 | 0 | 3.73 |
| 2024-08 | 0 | 4.32 |
| 2024-09 | 0 | 4.28 |
| 2024-10 | 0 | 5.72 |
| 2024-11 | 0 | 4.47 |
| 2024-12 | 0 | 3.73 |
| 2025-01 | 0 | 8.02 |
| 2025-02 | 0 | 4.63 |
| 2025-03 | 0 | 3.38 |
| 2025-04 | 0 | 3.86 |
| 2025-05 | 0 | 4.05 |
| 2025-06 | 0 | 3.87 |
| 2025-07 | 0 | 4 |
| 2025-08 | 0 | 4.85 |
| 2025-09 | 0 | 3.61 |
| 2025-10 | 0 | 5.35 |
| 2025-11 | 0 | 3.9 |
| 2025-12 | 0 | 5.05 |
| 2026-01 | 0 | 5.21 |
| 2026-02 | 0 | 4.28 |
| 2026-03 | 0 | 7.08 |
| 2026-04 | 0 | 6.17 |
| 2026-05 | 0 | 8.19 |
| 2026-06 | 0 | 5.1 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K203005 — cites (transitively): K200935 (d1), K182077 (d2), K162309 (d3), K170011 (d3), K180307 (d3), K050438 (d4), K133444 (d4), K153660 (d4), K163221 (d4), K150216 (d5), K992927 (d5), K111019 (d5), K152041 (d5), K073714 (d6), K120812 (d6), K140167 (d6), K110911 (d7), K113228 (d7), K022414 (d8) — cited as predicate by K211441, K214011, K230064, K241517
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MAZOR ROBOTICS LTD
Nothing in the loaded window.