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"icotec Systems, Handle, 1/4"" Coupling"
Model 42-892 · icotec AG · DI 07640172553848
NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070
NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
PML — Bone Cement, Posterior Screw Augmentation · Class II · 21 CFR 888.3027
UDILibrary device dossier · generated 2026-09-06 · 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
2.41
2019-02
0
2.93
2019-03
0
2.61
2019-04
0
2.53
2019-05
0
2.7
2019-06
0
2.64
2019-07
0
2.42
2019-08
0
2.88
2019-09
0
2.43
2019-10
0
2.87
2019-11
0
3.84
2019-12
0
2.53
2020-01
0
3.05
2020-02
0
3.6
2020-03
0
3.39
2020-04
0
4.65
2020-05
0
2.45
2020-06
0
2.58
2020-07
0
2.86
2020-08
0
2.29
2020-09
0
3.02
2020-10
0
4.28
2020-11
0
3.62
2020-12
0
2.97
2021-01
0
3.48
2021-02
0
3.05
2021-03
0
3.13
2021-04
0
3.06
2021-05
0
3.2
2021-06
0
3.07
2021-07
0
5.25
2021-08
0
2.46
2021-09
0
2.37
2021-10
0
2.37
2021-11
0
2.82
2021-12
0
2.56
2022-01
0
2.35
2022-02
0
2.59
2022-03
0
2.56
2022-04
0
2.27
2022-05
0
3.04
2022-06
0
3.27
2022-07
0
3.79
2022-08
0
2.41
2022-09
0
2.56
2022-10
0
2.64
2022-11
0
2.71
2022-12
0
3.18
2023-01
0
2.7
2023-02
0
2.79
2023-03
0
2.86
2023-04
0
2.54
2023-05
0
2.5
2023-06
0
2.15
2023-07
0
2.41
2023-08
0
2.34
2023-09
0
3.39
2023-10
0
2.96
2023-11
0
5.72
2023-12
0
3.03
2024-01
0
2.77
2024-02
0
3.26
2024-03
0
3.78
2024-04
0
2.74
2024-05
0
4.17
2024-06
0
3.59
2024-07
0
3.01
2024-08
0
3.25
2024-09
0
3.89
2024-10
0
4.46
2024-11
0
3.59
2024-12
0
3.09
2025-01
0
6.01
2025-02
0
3.56
2025-03
0
2.96
2025-04
0
3.31
2025-05
0
3.61
2025-06
0
3.51
2025-07
0
3.24
2025-08
0
3.82
2025-09
0
2.99
2025-10
0
3.22
2025-11
0
3.22
2025-12
0
3.85
2026-01
0
3.58
2026-02
0
3.38
2026-03
0
3.3
2026-04
0
3.01
2026-05
0
3.92
2026-06
0
3.83
This device (reports/month)Average device in NKB, NKG, OLO, PML (reports/device/month)