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Unnamed device

Model 945SPK1004 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00613994329523

ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820

GXZ — Electrode, Needle · Class II · 21 CFR 882.1350

UDILibrary device dossier · generated 2026-09-14 · 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.

4812162019-01: 0 reports for this device; peer average 2.53/device2019-02: 0 reports for this device; peer average 3.08/device2019-03: 0 reports for this device; peer average 2.8/device2019-04: 0 reports for this device; peer average 1.63/device2019-05: 0 reports for this device; peer average 2.17/device2019-06: 0 reports for this device; peer average 1.5/device2019-07: 0 reports for this device; peer average 1.53/device2019-08: 0 reports for this device; peer average 3.77/device2019-09: 0 reports for this device; peer average 2.69/device2019-10: 0 reports for this device; peer average 3.29/device2019-11: 0 reports for this device; peer average 3.71/device2019-12: 0 reports for this device; peer average 4.11/device2020-01: 0 reports for this device; peer average 2.65/device2020-02: 0 reports for this device; peer average 1.91/device2020-03: 0 reports for this device; peer average 3.32/device2020-04: 0 reports for this device; peer average 2.27/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1.63/device2020-07: 0 reports for this device; peer average 2.13/device2020-08: 0 reports for this device; peer average 2.69/device2020-09: 0 reports for this device; peer average 2.65/device2020-10: 0 reports for this device; peer average 3.66/device2020-11: 0 reports for this device; peer average 2.63/device2020-12: 0 reports for this device; peer average 2.47/device2021-01: 0 reports for this device; peer average 1.2/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.65/device2021-04: 0 reports for this device; peer average 1.82/device2021-05: 0 reports for this device; peer average 1.52/device2021-06: 0 reports for this device; peer average 2.11/device2021-07: 0 reports for this device; peer average 2.5/device2021-08: 0 reports for this device; peer average 2.29/device2021-09: 0 reports for this device; peer average 3.6/device2021-10: 0 reports for this device; peer average 2.45/device2021-11: 0 reports for this device; peer average 1.75/device2021-12: 0 reports for this device; peer average 1.44/device2022-01: 0 reports for this device; peer average 1.95/device2022-02: 0 reports for this device; peer average 1.76/device2022-03: 0 reports for this device; peer average 1.29/device2022-04: 0 reports for this device; peer average 2.33/device2022-05: 0 reports for this device; peer average 2.76/device2022-06: 0 reports for this device; peer average 2.11/device2022-07: 0 reports for this device; peer average 1.67/device2022-08: 0 reports for this device; peer average 2.16/device2022-09: 0 reports for this device; peer average 2.09/device2022-10: 0 reports for this device; peer average 2.3/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.87/device2023-01: 0 reports for this device; peer average 2.47/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2.27/device2023-04: 0 reports for this device; peer average 1.8/device2023-05: 0 reports for this device; peer average 2.31/device2023-06: 0 reports for this device; peer average 2.21/device2023-07: 0 reports for this device; peer average 1.73/device2023-08: 0 reports for this device; peer average 2.63/device2023-09: 0 reports for this device; peer average 3.18/device2023-10: 0 reports for this device; peer average 6.76/device2023-11: 0 reports for this device; peer average 5.55/device2023-12: 0 reports for this device; peer average 6.53/device2024-01: 0 reports for this device; peer average 4.9/device2024-02: 0 reports for this device; peer average 6.49/device2024-03: 0 reports for this device; peer average 5.06/device2024-04: 0 reports for this device; peer average 7.76/device2024-05: 0 reports for this device; peer average 7.8/device2024-06: 0 reports for this device; peer average 5.83/device2024-07: 0 reports for this device; peer average 9.32/device2024-08: 0 reports for this device; peer average 12.11/device2024-09: 0 reports for this device; peer average 14.76/device2024-10: 0 reports for this device; peer average 13.02/device2024-11: 0 reports for this device; peer average 11.41/device2024-12: 0 reports for this device; peer average 8.63/device2025-01: 0 reports for this device; peer average 8.51/device2025-02: 0 reports for this device; peer average 15.59/device2025-03: 0 reports for this device; peer average 10.85/device2025-04: 0 reports for this device; peer average 9.42/device2025-05: 0 reports for this device; peer average 8.22/device2025-06: 0 reports for this device; peer average 8.63/device2025-07: 0 reports for this device; peer average 16.3/device2025-08: 0 reports for this device; peer average 8.24/device2025-09: 0 reports for this device; peer average 9.38/device2025-10: 0 reports for this device; peer average 14.5/device2025-11: 0 reports for this device; peer average 12.39/device2025-12: 0 reports for this device; peer average 10.56/device2026-01: 0 reports for this device; peer average 9.1/device2026-02: 0 reports for this device; peer average 7.98/device2026-03: 0 reports for this device; peer average 9.96/device2026-04: 0 reports for this device; peer average 9.9/device2026-05: 0 reports for this device; peer average 10.58/device2026-06: 0 reports for this device; peer average 12.25/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.53
2019-0203.08
2019-0302.8
2019-0401.63
2019-0502.17
2019-0601.5
2019-0701.53
2019-0803.77
2019-0902.69
2019-1003.29
2019-1103.71
2019-1204.11
2020-0102.65
2020-0201.91
2020-0303.32
2020-0402.27
2020-0501.5
2020-0601.63
2020-0702.13
2020-0802.69
2020-0902.65
2020-1003.66
2020-1102.63
2020-1202.47
2021-0101.2
2021-0202
2021-0301.65
2021-0401.82
2021-0501.52
2021-0602.11
2021-0702.5
2021-0802.29
2021-0903.6
2021-1002.45
2021-1101.75
2021-1201.44
2022-0101.95
2022-0201.76
2022-0301.29
2022-0402.33
2022-0502.76
2022-0602.11
2022-0701.67
2022-0802.16
2022-0902.09
2022-1002.3
2022-1102
2022-1201.87
2023-0102.47
2023-0201.96
2023-0302.27
2023-0401.8
2023-0502.31
2023-0602.21
2023-0701.73
2023-0802.63
2023-0903.18
2023-1006.76
2023-1105.55
2023-1206.53
2024-0104.9
2024-0206.49
2024-0305.06
2024-0407.76
2024-0507.8
2024-0605.83
2024-0709.32
2024-08012.11
2024-09014.76
2024-10013.02
2024-11011.41
2024-1208.63
2025-0108.51
2025-02015.59
2025-03010.85
2025-0409.42
2025-0508.22
2025-0608.63
2025-07016.3
2025-0808.24
2025-0909.38
2025-10014.5
2025-11012.39
2025-12010.56
2026-0109.1
2026-0207.98
2026-0309.96
2026-0409.9
2026-05010.58
2026-06012.25
This device (reports/month)Average device in ETN, GXZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K062996 — cited as predicate by K103128, K110419, K112426

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
  • VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
  • VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
  • VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations