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GDLH® Posterior Spinal System

Model X0196-114 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00673978130392

KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050

MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070

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.

24672019-01: 0 reports for this device; peer average 2.11/device2019-02: 0 reports for this device; peer average 1.88/device2019-03: 0 reports for this device; peer average 1.97/device2019-04: 0 reports for this device; peer average 2.01/device2019-05: 0 reports for this device; peer average 2.29/device2019-06: 0 reports for this device; peer average 2.49/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 2.72/device2019-09: 0 reports for this device; peer average 1.76/device2019-10: 0 reports for this device; peer average 1.86/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 1.58/device2020-01: 0 reports for this device; peer average 2.39/device2020-02: 0 reports for this device; peer average 2.23/device2020-03: 0 reports for this device; peer average 2.22/device2020-04: 0 reports for this device; peer average 1.54/device2020-05: 0 reports for this device; peer average 2.24/device2020-06: 0 reports for this device; peer average 1.91/device2020-07: 0 reports for this device; peer average 1.77/device2020-08: 0 reports for this device; peer average 1.88/device2020-09: 0 reports for this device; peer average 2.18/device2020-10: 0 reports for this device; peer average 2.48/device2020-11: 0 reports for this device; peer average 2.3/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.17/device2021-02: 0 reports for this device; peer average 1.84/device2021-03: 0 reports for this device; peer average 2.35/device2021-04: 0 reports for this device; peer average 2.16/device2021-05: 0 reports for this device; peer average 1.95/device2021-06: 0 reports for this device; peer average 1.83/device2021-07: 0 reports for this device; peer average 7.35/device2021-08: 0 reports for this device; peer average 1.91/device2021-09: 0 reports for this device; peer average 1.69/device2021-10: 0 reports for this device; peer average 2.47/device2021-11: 0 reports for this device; peer average 2.18/device2021-12: 0 reports for this device; peer average 2.15/device2022-01: 0 reports for this device; peer average 2.13/device2022-02: 0 reports for this device; peer average 1.91/device2022-03: 0 reports for this device; peer average 1.76/device2022-04: 0 reports for this device; peer average 1.91/device2022-05: 0 reports for this device; peer average 1.74/device2022-06: 0 reports for this device; peer average 1.97/device2022-07: 0 reports for this device; peer average 3.55/device2022-08: 0 reports for this device; peer average 1.89/device2022-09: 0 reports for this device; peer average 2.75/device2022-10: 0 reports for this device; peer average 1.42/device2022-11: 0 reports for this device; peer average 1.7/device2022-12: 0 reports for this device; peer average 1.99/device2023-01: 0 reports for this device; peer average 1.58/device2023-02: 0 reports for this device; peer average 1.77/device2023-03: 0 reports for this device; peer average 1.8/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1.57/device2023-06: 0 reports for this device; peer average 1.71/device2023-07: 0 reports for this device; peer average 1.79/device2023-08: 0 reports for this device; peer average 1.37/device2023-09: 0 reports for this device; peer average 2.73/device2023-10: 0 reports for this device; peer average 2.6/device2023-11: 0 reports for this device; peer average 2.47/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 2.45/device2024-02: 0 reports for this device; peer average 2.15/device2024-03: 0 reports for this device; peer average 3.81/device2024-04: 0 reports for this device; peer average 1.76/device2024-05: 0 reports for this device; peer average 3.42/device2024-06: 0 reports for this device; peer average 2.01/device2024-07: 0 reports for this device; peer average 1.82/device2024-08: 0 reports for this device; peer average 1.95/device2024-09: 0 reports for this device; peer average 2.36/device2024-10: 0 reports for this device; peer average 2.09/device2024-11: 0 reports for this device; peer average 2.11/device2024-12: 0 reports for this device; peer average 1.75/device2025-01: 0 reports for this device; peer average 2.26/device2025-02: 0 reports for this device; peer average 2.43/device2025-03: 0 reports for this device; peer average 2.31/device2025-04: 0 reports for this device; peer average 2.32/device2025-05: 0 reports for this device; peer average 2.26/device2025-06: 0 reports for this device; peer average 2.16/device2025-07: 0 reports for this device; peer average 1.7/device2025-08: 0 reports for this device; peer average 1.93/device2025-09: 0 reports for this device; peer average 1.9/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.96/device2025-12: 0 reports for this device; peer average 2.25/device2026-01: 0 reports for this device; peer average 2.47/device2026-02: 0 reports for this device; peer average 2.44/device2026-03: 0 reports for this device; peer average 2.49/device2026-04: 0 reports for this device; peer average 1.84/device2026-05: 0 reports for this device; peer average 1.97/device2026-06: 0 reports for this device; peer average 4.64/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.11
2019-0201.88
2019-0301.97
2019-0402.01
2019-0502.29
2019-0602.49
2019-0701.67
2019-0802.72
2019-0901.76
2019-1001.86
2019-1102.2
2019-1201.58
2020-0102.39
2020-0202.23
2020-0302.22
2020-0401.54
2020-0502.24
2020-0601.91
2020-0701.77
2020-0801.88
2020-0902.18
2020-1002.48
2020-1102.3
2020-1202.07
2021-0102.17
2021-0201.84
2021-0302.35
2021-0402.16
2021-0501.95
2021-0601.83
2021-0707.35
2021-0801.91
2021-0901.69
2021-1002.47
2021-1102.18
2021-1202.15
2022-0102.13
2022-0201.91
2022-0301.76
2022-0401.91
2022-0501.74
2022-0601.97
2022-0703.55
2022-0801.89
2022-0902.75
2022-1001.42
2022-1101.7
2022-1201.99
2023-0101.58
2023-0201.77
2023-0301.8
2023-0402
2023-0501.57
2023-0601.71
2023-0701.79
2023-0801.37
2023-0902.73
2023-1002.6
2023-1102.47
2023-1201.62
2024-0102.45
2024-0202.15
2024-0303.81
2024-0401.76
2024-0503.42
2024-0602.01
2024-0701.82
2024-0801.95
2024-0902.36
2024-1002.09
2024-1102.11
2024-1201.75
2025-0102.26
2025-0202.43
2025-0302.31
2025-0402.32
2025-0502.26
2025-0602.16
2025-0701.7
2025-0801.93
2025-0901.9
2025-1002
2025-1101.96
2025-1202.25
2026-0102.47
2026-0202.44
2026-0302.49
2026-0401.84
2026-0501.97
2026-0604.64
This device (reports/month)Average device in KWP, MNH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K954645 — cited as predicate by K221646

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