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LexTOME
Model MUA00006 · MEDMETALEX CO., LTD. · DI 04589761815383
HTO — Reamer · Class I · 21 CFR 888.4540
UDILibrary device dossier · generated 2026-09-07 · 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
1.89
2019-02
0
1.38
2019-03
0
1.4
2019-04
0
1.43
2019-05
0
3
2019-06
0
3.23
2019-07
0
1.94
2019-08
0
4.47
2019-09
0
3.44
2019-10
0
3.31
2019-11
0
3.76
2019-12
0
4.07
2020-01
0
3.07
2020-02
0
3.11
2020-03
0
1.81
2020-04
0
1.35
2020-05
0
3.36
2020-06
0
1.4
2020-07
0
1.68
2020-08
0
2.89
2020-09
0
2.24
2020-10
0
2.91
2020-11
0
4.03
2020-12
0
4.95
2021-01
0
2.56
2021-02
0
3.25
2021-03
0
7.58
2021-04
0
6.11
2021-05
0
2.96
2021-06
0
10.58
2021-07
0
9.17
2021-08
0
6.3
2021-09
0
2.95
2021-10
0
7.23
2021-11
0
8.37
2021-12
0
5.81
2022-01
0
5.88
2022-02
0
4.1
2022-03
0
5.24
2022-04
0
2.56
2022-05
0
5.49
2022-06
0
3.81
2022-07
0
4.41
2022-08
0
4.51
2022-09
0
7.54
2022-10
0
6.75
2022-11
0
10
2022-12
0
3.91
2023-01
0
9.76
2023-02
0
5.79
2023-03
0
3.53
2023-04
0
2.84
2023-05
0
6.33
2023-06
0
7.64
2023-07
0
6
2023-08
0
10.31
2023-09
0
7.81
2023-10
0
7.13
2023-11
0
6.86
2023-12
0
4.27
2024-01
0
5.94
2024-02
0
18.12
2024-03
0
5.54
2024-04
0
9.95
2024-05
0
11.78
2024-06
0
6.74
2024-07
0
5.2
2024-08
0
4.32
2024-09
0
4.81
2024-10
0
2.9
2024-11
0
3.09
2024-12
0
2
2025-01
0
1.71
2025-02
0
1.29
2025-03
0
4
2025-04
0
1.28
2025-05
0
1.96
2025-06
0
2
2025-07
0
7.04
2025-08
0
2.79
2025-09
0
1.11
2025-10
0
1
2025-11
0
1.16
2025-12
0
1.74
2026-01
0
4.21
2026-02
0
2.52
2026-03
0
1.65
2026-04
0
13.87
2026-05
0
1.4
2026-06
0
1.95
This device (reports/month)Average device in HTO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MEDMETALEX CO., LTD.