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DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

Model 77367456 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00643169516182

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

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

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.

12342019-01: 0 reports for this device; peer average 2.12/device2019-02: 0 reports for this device; peer average 1.81/device2019-03: 0 reports for this device; peer average 1.8/device2019-04: 0 reports for this device; peer average 1.8/device2019-05: 0 reports for this device; peer average 1.94/device2019-06: 0 reports for this device; peer average 1.94/device2019-07: 0 reports for this device; peer average 1.77/device2019-08: 0 reports for this device; peer average 3.2/device2019-09: 0 reports for this device; peer average 1.72/device2019-10: 0 reports for this device; peer average 2.25/device2019-11: 0 reports for this device; peer average 2.13/device2019-12: 0 reports for this device; peer average 1.72/device2020-01: 0 reports for this device; peer average 2.64/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.92/device2020-04: 0 reports for this device; peer average 1.66/device2020-05: 0 reports for this device; peer average 2.1/device2020-06: 0 reports for this device; peer average 2.06/device2020-07: 0 reports for this device; peer average 1.99/device2020-08: 0 reports for this device; peer average 1.77/device2020-09: 0 reports for this device; peer average 2.23/device2020-10: 0 reports for this device; peer average 2.32/device2020-11: 0 reports for this device; peer average 2.64/device2020-12: 0 reports for this device; peer average 2.06/device2021-01: 0 reports for this device; peer average 1.73/device2021-02: 0 reports for this device; peer average 1.83/device2021-03: 0 reports for this device; peer average 2.26/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 1.83/device2021-06: 0 reports for this device; peer average 2.57/device2021-07: 0 reports for this device; peer average 2.18/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 1.87/device2021-10: 0 reports for this device; peer average 2.66/device2021-11: 0 reports for this device; peer average 2.05/device2021-12: 0 reports for this device; peer average 2.35/device2022-01: 0 reports for this device; peer average 2.15/device2022-02: 0 reports for this device; peer average 2.06/device2022-03: 0 reports for this device; peer average 1.79/device2022-04: 0 reports for this device; peer average 1.7/device2022-05: 0 reports for this device; peer average 1.94/device2022-06: 0 reports for this device; peer average 2.1/device2022-07: 0 reports for this device; peer average 3.21/device2022-08: 0 reports for this device; peer average 2.19/device2022-09: 0 reports for this device; peer average 2.74/device2022-10: 0 reports for this device; peer average 1.57/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2.06/device2023-01: 0 reports for this device; peer average 2.03/device2023-02: 0 reports for this device; peer average 2.1/device2023-03: 0 reports for this device; peer average 2.15/device2023-04: 0 reports for this device; peer average 1.69/device2023-05: 0 reports for this device; peer average 1.93/device2023-06: 0 reports for this device; peer average 1.56/device2023-07: 0 reports for this device; peer average 1.89/device2023-08: 0 reports for this device; peer average 2.03/device2023-09: 0 reports for this device; peer average 2.43/device2023-10: 0 reports for this device; peer average 2.31/device2023-11: 0 reports for this device; peer average 2.27/device2023-12: 0 reports for this device; peer average 1.75/device2024-01: 0 reports for this device; peer average 2.38/device2024-02: 0 reports for this device; peer average 2.1/device2024-03: 0 reports for this device; peer average 3.52/device2024-04: 0 reports for this device; peer average 1.65/device2024-05: 0 reports for this device; peer average 2.93/device2024-06: 0 reports for this device; peer average 3.36/device2024-07: 0 reports for this device; peer average 2.13/device2024-08: 0 reports for this device; peer average 1.78/device2024-09: 0 reports for this device; peer average 2.9/device2024-10: 0 reports for this device; peer average 2.14/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.66/device2025-01: 0 reports for this device; peer average 2.19/device2025-02: 0 reports for this device; peer average 2.44/device2025-03: 0 reports for this device; peer average 2.23/device2025-04: 0 reports for this device; peer average 2.16/device2025-05: 0 reports for this device; peer average 2.55/device2025-06: 0 reports for this device; peer average 2.27/device2025-07: 0 reports for this device; peer average 2.07/device2025-08: 0 reports for this device; peer average 1.98/device2025-09: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1.86/device2025-11: 0 reports for this device; peer average 1.96/device2025-12: 0 reports for this device; peer average 2.56/device2026-01: 0 reports for this device; peer average 2.51/device2026-02: 0 reports for this device; peer average 2.34/device2026-03: 0 reports for this device; peer average 2.68/device2026-04: 0 reports for this device; peer average 1.92/device2026-05: 0 reports for this device; peer average 2.34/device2026-06: 0 reports for this device; peer average 4.07/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
2019-0201.81
2019-0301.8
2019-0401.8
2019-0501.94
2019-0601.94
2019-0701.77
2019-0803.2
2019-0901.72
2019-1002.25
2019-1102.13
2019-1201.72
2020-0102.64
2020-0202.04
2020-0301.92
2020-0401.66
2020-0502.1
2020-0602.06
2020-0701.99
2020-0801.77
2020-0902.23
2020-1002.32
2020-1102.64
2020-1202.06
2021-0101.73
2021-0201.83
2021-0302.26
2021-0401.88
2021-0501.83
2021-0602.57
2021-0702.18
2021-0802.21
2021-0901.87
2021-1002.66
2021-1102.05
2021-1202.35
2022-0102.15
2022-0202.06
2022-0301.79
2022-0401.7
2022-0501.94
2022-0602.1
2022-0703.21
2022-0802.19
2022-0902.74
2022-1001.57
2022-1102.09
2022-1202.06
2023-0102.03
2023-0202.1
2023-0302.15
2023-0401.69
2023-0501.93
2023-0601.56
2023-0701.89
2023-0802.03
2023-0902.43
2023-1002.31
2023-1102.27
2023-1201.75
2024-0102.38
2024-0202.1
2024-0303.52
2024-0401.65
2024-0502.93
2024-0603.36
2024-0702.13
2024-0801.78
2024-0902.9
2024-1002.14
2024-1101.69
2024-1201.66
2025-0102.19
2025-0202.44
2025-0302.23
2025-0402.16
2025-0502.55
2025-0602.27
2025-0702.07
2025-0801.98
2025-0902
2025-1001.86
2025-1101.96
2025-1202.56
2026-0102.51
2026-0202.34
2026-0302.68
2026-0401.92
2026-0502.34
2026-0604.07
This device (reports/month)Average device in KWQ, ODP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142450 — cites (transitively): K140417 (d1), K030327 (d2), K094042 (d2), K100967 (d2), K132584 (d2), P000028 (d2), K073285 (d3), K100214 (d3), K132594 (d3), P980048 (d3), K091088 (d4), K092336 (d4), K083447 (d4) — cited as predicate by K150135, K163366, K192502

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