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A.L.P.S. mvX™
Model 770104010 · Tyber Medical, LLC · DI 00196449016594
HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030
HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-15 · 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
2.03
2019-02
0
1.58
2019-03
0
1.76
2019-04
0
2.29
2019-05
0
1.73
2019-06
0
1.74
2019-07
0
1.89
2019-08
0
1.84
2019-09
0
1.72
2019-10
0
1.63
2019-11
0
1.91
2019-12
0
2.26
2020-01
0
2.4
2020-02
0
1.49
2020-03
0
1.77
2020-04
0
1.93
2020-05
0
1.84
2020-06
0
2.03
2020-07
0
2.34
2020-08
0
2.44
2020-09
0
2.67
2020-10
0
2.1
2020-11
0
2.64
2020-12
0
2.38
2021-01
0
1.83
2021-02
0
2.18
2021-03
0
2.38
2021-04
0
2.74
2021-05
0
2.49
2021-06
0
2.14
2021-07
0
2.27
2021-08
0
2.01
2021-09
0
2.23
2021-10
0
2.05
2021-11
0
2.22
2021-12
0
2.29
2022-01
0
2.93
2022-02
0
2.15
2022-03
0
1.91
2022-04
0
2.05
2022-05
0
2.2
2022-06
0
2.26
2022-07
0
2.21
2022-08
0
2.42
2022-09
0
2.69
2022-10
0
2.96
2022-11
0
2.98
2022-12
0
4.53
2023-01
0
2.64
2023-02
0
2.76
2023-03
0
3.04
2023-04
0
2.92
2023-05
0
3.6
2023-06
0
2.93
2023-07
0
2.24
2023-08
0
2.22
2023-09
0
2.02
2023-10
0
2.26
2023-11
0
1.96
2023-12
0
2.59
2024-01
0
2.6
2024-02
0
1.91
2024-03
0
2.2
2024-04
0
2.19
2024-05
0
2.32
2024-06
0
2.56
2024-07
0
2.46
2024-08
0
2.16
2024-09
0
2
2024-10
0
2.25
2024-11
0
1.94
2024-12
0
2.77
2025-01
0
2.05
2025-02
0
2.22
2025-03
0
2.34
2025-04
0
2.32
2025-05
0
2.52
2025-06
0
1.87
2025-07
0
2.18
2025-08
0
2.28
2025-09
0
1.98
2025-10
0
2.35
2025-11
0
2.02
2025-12
0
2.6
2026-01
0
1.98
2026-02
0
2.19
2026-03
0
2.81
2026-04
0
2.22
2026-05
0
2.44
2026-06
0
2.2
This device (reports/month)Average device in HRS, HTN, HWC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Tyber Medical, LLC