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Bendini
Model 8210322 · Nuvasive, Inc. · DI 00887517728203
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870
HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560
IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820
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
8.04
2019-02
0
8.62
2019-03
0
8.68
2019-04
0
9.69
2019-05
0
10.96
2019-06
0
11.15
2019-07
0
7.92
2019-08
0
6.79
2019-09
0
6.65
2019-10
0
6.66
2019-11
0
8.51
2019-12
0
8.89
2020-01
0
6.74
2020-02
0
7.78
2020-03
0
8.57
2020-04
0
7.42
2020-05
0
8.69
2020-06
0
7.44
2020-07
0
8.49
2020-08
0
7.06
2020-09
0
7.69
2020-10
0
8.57
2020-11
0
9.29
2020-12
0
7.69
2021-01
0
8.06
2021-02
0
8.46
2021-03
0
8.07
2021-04
0
7.06
2021-05
0
8
2021-06
0
8.8
2021-07
0
7.57
2021-08
0
7.61
2021-09
0
11.18
2021-10
0
7.02
2021-11
0
8.74
2021-12
0
6.02
2022-01
0
5.73
2022-02
0
5.67
2022-03
0
7.88
2022-04
0
5.65
2022-05
0
6.79
2022-06
0
7.57
2022-07
0
6.12
2022-08
0
6.47
2022-09
0
6.02
2022-10
0
8.67
2022-11
0
7.82
2022-12
0
7.13
2023-01
0
6.39
2023-02
0
6.06
2023-03
0
7.21
2023-04
0
6.82
2023-05
0
8.41
2023-06
0
9.71
2023-07
0
9.66
2023-08
0
8.94
2023-09
0
8.48
2023-10
0
9.42
2023-11
0
10.9
2023-12
0
10.55
2024-01
0
12.03
2024-02
0
10.26
2024-03
0
11.23
2024-04
0
11.4
2024-05
0
11.22
2024-06
0
9.86
2024-07
0
12.49
2024-08
0
16.55
2024-09
0
15.62
2024-10
0
16.75
2024-11
0
11.25
2024-12
0
10.12
2025-01
0
11.43
2025-02
0
13.97
2025-03
0
12.98
2025-04
0
12.6
2025-05
0
11.53
2025-06
0
14.36
2025-07
0
13.77
2025-08
0
10.07
2025-09
0
10.79
2025-10
0
11.97
2025-11
0
10.56
2025-12
0
9.91
2026-01
0
9.94
2026-02
0
8.59
2026-03
0
9.73
2026-04
0
8.74
2026-05
0
9.42
2026-06
0
7.98
This device (reports/month)Average device in ETN, GWF, HAW, IKN, OLO, PDQ (reports/device/month)