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VERTE-SPAN® Spinal System

Model 8914000 · MEDTRONIC SOFAMOR DANEK, INC. · DI 20721902068342

KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

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.

12342019-01: 0 reports for this device; peer average 2.12/device2019-02: 0 reports for this device; peer average 1.82/device2019-03: 0 reports for this device; peer average 1.87/device2019-04: 0 reports for this device; peer average 1.79/device2019-05: 0 reports for this device; peer average 1.92/device2019-06: 0 reports for this device; peer average 2.05/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 2.75/device2019-09: 0 reports for this device; peer average 1.71/device2019-10: 0 reports for this device; peer average 2.01/device2019-11: 0 reports for this device; peer average 2.11/device2019-12: 0 reports for this device; peer average 1.72/device2020-01: 0 reports for this device; peer average 2.58/device2020-02: 0 reports for this device; peer average 1.96/device2020-03: 0 reports for this device; peer average 1.92/device2020-04: 0 reports for this device; peer average 1.64/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.05/device2020-07: 0 reports for this device; peer average 2.09/device2020-08: 0 reports for this device; peer average 1.82/device2020-09: 0 reports for this device; peer average 2.14/device2020-10: 0 reports for this device; peer average 2.23/device2020-11: 0 reports for this device; peer average 2.39/device2020-12: 0 reports for this device; peer average 1.95/device2021-01: 0 reports for this device; peer average 1.67/device2021-02: 0 reports for this device; peer average 1.75/device2021-03: 0 reports for this device; peer average 2.19/device2021-04: 0 reports for this device; peer average 1.87/device2021-05: 0 reports for this device; peer average 1.74/device2021-06: 0 reports for this device; peer average 2.18/device2021-07: 0 reports for this device; peer average 2.13/device2021-08: 0 reports for this device; peer average 2.13/device2021-09: 0 reports for this device; peer average 1.81/device2021-10: 0 reports for this device; peer average 2.58/device2021-11: 0 reports for this device; peer average 2.04/device2021-12: 0 reports for this device; peer average 2.29/device2022-01: 0 reports for this device; peer average 2.1/device2022-02: 0 reports for this device; peer average 2.01/device2022-03: 0 reports for this device; peer average 1.77/device2022-04: 0 reports for this device; peer average 1.73/device2022-05: 0 reports for this device; peer average 1.93/device2022-06: 0 reports for this device; peer average 2.07/device2022-07: 0 reports for this device; peer average 3.03/device2022-08: 0 reports for this device; peer average 2.15/device2022-09: 0 reports for this device; peer average 2.77/device2022-10: 0 reports for this device; peer average 1.58/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.03/device2023-02: 0 reports for this device; peer average 2.04/device2023-03: 0 reports for this device; peer average 2.3/device2023-04: 0 reports for this device; peer average 1.7/device2023-05: 0 reports for this device; peer average 1.84/device2023-06: 0 reports for this device; peer average 1.57/device2023-07: 0 reports for this device; peer average 1.95/device2023-08: 0 reports for this device; peer average 1.4/device2023-09: 0 reports for this device; peer average 2.45/device2023-10: 0 reports for this device; peer average 2.3/device2023-11: 0 reports for this device; peer average 2.16/device2023-12: 0 reports for this device; peer average 1.65/device2024-01: 0 reports for this device; peer average 2.34/device2024-02: 0 reports for this device; peer average 2.07/device2024-03: 0 reports for this device; peer average 3.42/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 2.97/device2024-06: 0 reports for this device; peer average 3.28/device2024-07: 0 reports for this device; peer average 2.05/device2024-08: 0 reports for this device; peer average 1.62/device2024-09: 0 reports for this device; peer average 2.74/device2024-10: 0 reports for this device; peer average 2.03/device2024-11: 0 reports for this device; peer average 1.66/device2024-12: 0 reports for this device; peer average 1.61/device2025-01: 0 reports for this device; peer average 2.06/device2025-02: 0 reports for this device; peer average 2.41/device2025-03: 0 reports for this device; peer average 2.55/device2025-04: 0 reports for this device; peer average 2.12/device2025-05: 0 reports for this device; peer average 2.57/device2025-06: 0 reports for this device; peer average 2.17/device2025-07: 0 reports for this device; peer average 1.9/device2025-08: 0 reports for this device; peer average 1.98/device2025-09: 0 reports for this device; peer average 1.92/device2025-10: 0 reports for this device; peer average 1.87/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 2.44/device2026-01: 0 reports for this device; peer average 2.39/device2026-02: 0 reports for this device; peer average 2.27/device2026-03: 0 reports for this device; peer average 2.52/device2026-04: 0 reports for this device; peer average 1.94/device2026-05: 0 reports for this device; peer average 2.27/device2026-06: 0 reports for this device; peer average 3.96/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.12
2019-0201.82
2019-0301.87
2019-0401.79
2019-0501.92
2019-0602.05
2019-0701.69
2019-0802.75
2019-0901.71
2019-1002.01
2019-1102.11
2019-1201.72
2020-0102.58
2020-0201.96
2020-0301.92
2020-0401.64
2020-0502
2020-0602.05
2020-0702.09
2020-0801.82
2020-0902.14
2020-1002.23
2020-1102.39
2020-1201.95
2021-0101.67
2021-0201.75
2021-0302.19
2021-0401.87
2021-0501.74
2021-0602.18
2021-0702.13
2021-0802.13
2021-0901.81
2021-1002.58
2021-1102.04
2021-1202.29
2022-0102.1
2022-0202.01
2022-0301.77
2022-0401.73
2022-0501.93
2022-0602.07
2022-0703.03
2022-0802.15
2022-0902.77
2022-1001.58
2022-1102.06
2022-1202
2023-0102.03
2023-0202.04
2023-0302.3
2023-0401.7
2023-0501.84
2023-0601.57
2023-0701.95
2023-0801.4
2023-0902.45
2023-1002.3
2023-1102.16
2023-1201.65
2024-0102.34
2024-0202.07
2024-0303.42
2024-0401.65
2024-0502.97
2024-0603.28
2024-0702.05
2024-0801.62
2024-0902.74
2024-1002.03
2024-1101.66
2024-1201.61
2025-0102.06
2025-0202.41
2025-0302.55
2025-0402.12
2025-0502.57
2025-0602.17
2025-0701.9
2025-0801.98
2025-0901.92
2025-1001.87
2025-1101.87
2025-1202.44
2026-0102.39
2026-0202.27
2026-0302.52
2026-0401.94
2026-0502.27
2026-0603.96
This device (reports/month)Average device in KWQ, MQP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K010930 — cited as predicate by K083186

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