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Alpine Stirrups, Metric, Right
Model RT-5100-54R-CE · Qfix · DI 00841962120555
IZI — System, X-Ray, Angiographic · Class II · 21 CFR 892.1600
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
KPS — System, Tomography, Computed, Emission · Class II · 21 CFR 892.1200
LNH — System, Nuclear Magnetic Resonance Imaging · Class II · 21 CFR 892.1000
OUO — Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance · Class II · 21 CFR 892.1200
OWB — Interventional Fluoroscopic X-Ray System · Class II · 21 CFR 892.1650
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
7.08
2019-02
0
4.81
2019-03
0
5.52
2019-04
0
8.05
2019-05
0
5.79
2019-06
0
4.83
2019-07
0
5.13
2019-08
0
6.55
2019-09
0
4.95
2019-10
0
4.14
2019-11
0
4.27
2019-12
0
5.36
2020-01
0
4.13
2020-02
0
4.91
2020-03
0
5.88
2020-04
0
7.89
2020-05
0
4.94
2020-06
0
5.04
2020-07
0
3.79
2020-08
0
3.51
2020-09
0
3.4
2020-10
0
3.6
2020-11
0
3.55
2020-12
0
3.38
2021-01
0
3.18
2021-02
0
3.66
2021-03
0
4
2021-04
0
5.19
2021-05
0
4.98
2021-06
0
6.36
2021-07
0
3.98
2021-08
0
5.87
2021-09
0
6.52
2021-10
0
4.93
2021-11
0
5.63
2021-12
0
5.7
2022-01
0
4.4
2022-02
0
4.64
2022-03
0
5.15
2022-04
0
5.13
2022-05
0
7.18
2022-06
0
5.08
2022-07
0
5.46
2022-08
0
5.34
2022-09
0
5.32
2022-10
0
19.06
2022-11
0
39.51
2022-12
0
37.2
2023-01
0
50.12
2023-02
0
32.62
2023-03
0
59.42
2023-04
0
40.69
2023-05
0
38.23
2023-06
0
32
2023-07
0
22.88
2023-08
0
25.83
2023-09
0
38.53
2023-10
0
34.44
2023-11
0
41.33
2023-12
0
38.99
2024-01
0
40.64
2024-02
0
58.57
2024-03
0
38.1
2024-04
0
32.63
2024-05
0
32.38
2024-06
0
35.75
2024-07
0
38.26
2024-08
0
45.38
2024-09
0
45
2024-10
0
37.23
2024-11
0
28.36
2024-12
0
31.11
2025-01
0
30.38
2025-02
0
40.75
2025-03
0
27.56
2025-04
0
57.03
2025-05
0
52.68
2025-06
0
49.38
2025-07
0
51.01
2025-08
0
76.07
2025-09
0
113.16
2025-10
0
110.86
2025-11
0
75.6
2025-12
0
26.81
2026-01
0
28.67
2026-02
0
18.35
2026-03
0
21.47
2026-04
0
16.43
2026-05
0
19.76
2026-06
0
16.1
This device (reports/month)Average device in IZI, JAK, KPS, LNH, OUO, OWB (reports/device/month)