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POWEREASE™ Instruments

Model 2342393M · MEDTRONIC SOFAMOR DANEK, INC. · DI 00613994649683

GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870

HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310

HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment · Class I · 21 CFR 878.4820

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.

368112019-01: 0 reports for this device; peer average 2.6/device2019-02: 0 reports for this device; peer average 3.59/device2019-03: 0 reports for this device; peer average 3.95/device2019-04: 0 reports for this device; peer average 3.38/device2019-05: 0 reports for this device; peer average 3.72/device2019-06: 0 reports for this device; peer average 3.6/device2019-07: 0 reports for this device; peer average 3.12/device2019-08: 0 reports for this device; peer average 4.2/device2019-09: 0 reports for this device; peer average 3.57/device2019-10: 0 reports for this device; peer average 3.61/device2019-11: 0 reports for this device; peer average 4.18/device2019-12: 0 reports for this device; peer average 4.78/device2020-01: 0 reports for this device; peer average 3.71/device2020-02: 0 reports for this device; peer average 4.11/device2020-03: 0 reports for this device; peer average 5.18/device2020-04: 0 reports for this device; peer average 3.08/device2020-05: 0 reports for this device; peer average 3.01/device2020-06: 0 reports for this device; peer average 3.69/device2020-07: 0 reports for this device; peer average 3.49/device2020-08: 0 reports for this device; peer average 3.41/device2020-09: 0 reports for this device; peer average 4.23/device2020-10: 0 reports for this device; peer average 3.8/device2020-11: 0 reports for this device; peer average 3.97/device2020-12: 0 reports for this device; peer average 4.02/device2021-01: 0 reports for this device; peer average 3.21/device2021-02: 0 reports for this device; peer average 3.73/device2021-03: 0 reports for this device; peer average 3.71/device2021-04: 0 reports for this device; peer average 3.14/device2021-05: 0 reports for this device; peer average 3.48/device2021-06: 0 reports for this device; peer average 3.41/device2021-07: 0 reports for this device; peer average 3.24/device2021-08: 0 reports for this device; peer average 3.63/device2021-09: 0 reports for this device; peer average 3.29/device2021-10: 0 reports for this device; peer average 2.74/device2021-11: 0 reports for this device; peer average 3.15/device2021-12: 0 reports for this device; peer average 3.24/device2022-01: 0 reports for this device; peer average 2.88/device2022-02: 0 reports for this device; peer average 3.24/device2022-03: 0 reports for this device; peer average 3.62/device2022-04: 0 reports for this device; peer average 2.71/device2022-05: 0 reports for this device; peer average 3.27/device2022-06: 0 reports for this device; peer average 3.84/device2022-07: 0 reports for this device; peer average 2.86/device2022-08: 0 reports for this device; peer average 3.38/device2022-09: 0 reports for this device; peer average 4.15/device2022-10: 0 reports for this device; peer average 3.45/device2022-11: 0 reports for this device; peer average 3.77/device2022-12: 0 reports for this device; peer average 4.11/device2023-01: 0 reports for this device; peer average 2.95/device2023-02: 0 reports for this device; peer average 3.42/device2023-03: 0 reports for this device; peer average 3.4/device2023-04: 0 reports for this device; peer average 2.74/device2023-05: 0 reports for this device; peer average 3.98/device2023-06: 0 reports for this device; peer average 3.63/device2023-07: 0 reports for this device; peer average 2.98/device2023-08: 0 reports for this device; peer average 3.43/device2023-09: 0 reports for this device; peer average 3.59/device2023-10: 0 reports for this device; peer average 3.16/device2023-11: 0 reports for this device; peer average 4.98/device2023-12: 0 reports for this device; peer average 4.51/device2024-01: 0 reports for this device; peer average 3.32/device2024-02: 0 reports for this device; peer average 4.44/device2024-03: 0 reports for this device; peer average 4.56/device2024-04: 0 reports for this device; peer average 4.25/device2024-05: 0 reports for this device; peer average 5.29/device2024-06: 0 reports for this device; peer average 5.06/device2024-07: 0 reports for this device; peer average 4.14/device2024-08: 0 reports for this device; peer average 5.5/device2024-09: 0 reports for this device; peer average 7.47/device2024-10: 0 reports for this device; peer average 5/device2024-11: 0 reports for this device; peer average 5.9/device2024-12: 0 reports for this device; peer average 5.27/device2025-01: 0 reports for this device; peer average 3.75/device2025-02: 0 reports for this device; peer average 5.92/device2025-03: 0 reports for this device; peer average 6.61/device2025-04: 0 reports for this device; peer average 3.62/device2025-05: 0 reports for this device; peer average 4.66/device2025-06: 0 reports for this device; peer average 5.33/device2025-07: 0 reports for this device; peer average 4.7/device2025-08: 0 reports for this device; peer average 4.59/device2025-09: 0 reports for this device; peer average 4.77/device2025-10: 0 reports for this device; peer average 4.76/device2025-11: 0 reports for this device; peer average 6.48/device2025-12: 0 reports for this device; peer average 6.2/device2026-01: 0 reports for this device; peer average 3.77/device2026-02: 0 reports for this device; peer average 4.74/device2026-03: 0 reports for this device; peer average 5.51/device2026-04: 0 reports for this device; peer average 5.51/device2026-05: 0 reports for this device; peer average 6.09/device2026-06: 0 reports for this device; peer average 11.11/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.6
2019-0203.59
2019-0303.95
2019-0403.38
2019-0503.72
2019-0603.6
2019-0703.12
2019-0804.2
2019-0903.57
2019-1003.61
2019-1104.18
2019-1204.78
2020-0103.71
2020-0204.11
2020-0305.18
2020-0403.08
2020-0503.01
2020-0603.69
2020-0703.49
2020-0803.41
2020-0904.23
2020-1003.8
2020-1103.97
2020-1204.02
2021-0103.21
2021-0203.73
2021-0303.71
2021-0403.14
2021-0503.48
2021-0603.41
2021-0703.24
2021-0803.63
2021-0903.29
2021-1002.74
2021-1103.15
2021-1203.24
2022-0102.88
2022-0203.24
2022-0303.62
2022-0402.71
2022-0503.27
2022-0603.84
2022-0702.86
2022-0803.38
2022-0904.15
2022-1003.45
2022-1103.77
2022-1204.11
2023-0102.95
2023-0203.42
2023-0303.4
2023-0402.74
2023-0503.98
2023-0603.63
2023-0702.98
2023-0803.43
2023-0903.59
2023-1003.16
2023-1104.98
2023-1204.51
2024-0103.32
2024-0204.44
2024-0304.56
2024-0404.25
2024-0505.29
2024-0605.06
2024-0704.14
2024-0805.5
2024-0907.47
2024-1005
2024-1105.9
2024-1205.27
2025-0103.75
2025-0205.92
2025-0306.61
2025-0403.62
2025-0504.66
2025-0605.33
2025-0704.7
2025-0804.59
2025-0904.77
2025-1004.76
2025-1106.48
2025-1206.2
2026-0103.77
2026-0204.74
2026-0305.51
2026-0405.51
2026-0506.09
2026-06011.11
This device (reports/month)Average device in GWF, HBE, HWE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K111520 — cites (transitively): K061113 (d1), K061639 (d1), K063305 (d1), K081475 (d1) — cited as predicate by K143019, K153442, K153463, K161210, K170679, K173338, K181111, K182121, K182436, K201407, K203291, K210637, K211596, K214011, K231184

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