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TSRH® Spinal System

Model 83585609H · MEDTRONIC SOFAMOR DANEK, INC. · DI 00613994888129

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

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

MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070

NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070

UDILibrary device dossier · generated 2026-09-15 · 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.

23572019-01: 0 reports for this device; peer average 2.11/device2019-02: 0 reports for this device; peer average 1.95/device2019-03: 0 reports for this device; peer average 1.98/device2019-04: 0 reports for this device; peer average 2.02/device2019-05: 0 reports for this device; peer average 2.28/device2019-06: 0 reports for this device; peer average 2.56/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 2.81/device2019-09: 0 reports for this device; peer average 1.75/device2019-10: 0 reports for this device; peer average 1.88/device2019-11: 0 reports for this device; peer average 2.26/device2019-12: 0 reports for this device; peer average 1.63/device2020-01: 0 reports for this device; peer average 2.38/device2020-02: 0 reports for this device; peer average 2.24/device2020-03: 0 reports for this device; peer average 2.23/device2020-04: 0 reports for this device; peer average 1.58/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 1.86/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.94/device2020-09: 0 reports for this device; peer average 2.39/device2020-10: 0 reports for this device; peer average 2.58/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2.03/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 1.86/device2021-03: 0 reports for this device; peer average 2.44/device2021-04: 0 reports for this device; peer average 2.26/device2021-05: 0 reports for this device; peer average 1.99/device2021-06: 0 reports for this device; peer average 1.95/device2021-07: 0 reports for this device; peer average 6.61/device2021-08: 0 reports for this device; peer average 1.95/device2021-09: 0 reports for this device; peer average 1.76/device2021-10: 0 reports for this device; peer average 2.52/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 2.3/device2022-01: 0 reports for this device; peer average 2.13/device2022-02: 0 reports for this device; peer average 1.96/device2022-03: 0 reports for this device; peer average 1.84/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 1.8/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 3.96/device2022-08: 0 reports for this device; peer average 1.87/device2022-09: 0 reports for this device; peer average 2.71/device2022-10: 0 reports for this device; peer average 1.46/device2022-11: 0 reports for this device; peer average 1.78/device2022-12: 0 reports for this device; peer average 2.08/device2023-01: 0 reports for this device; peer average 1.71/device2023-02: 0 reports for this device; peer average 1.78/device2023-03: 0 reports for this device; peer average 1.78/device2023-04: 0 reports for this device; peer average 1.98/device2023-05: 0 reports for this device; peer average 1.56/device2023-06: 0 reports for this device; peer average 1.74/device2023-07: 0 reports for this device; peer average 1.91/device2023-08: 0 reports for this device; peer average 1.64/device2023-09: 0 reports for this device; peer average 2.73/device2023-10: 0 reports for this device; peer average 2.68/device2023-11: 0 reports for this device; peer average 2.54/device2023-12: 0 reports for this device; peer average 1.68/device2024-01: 0 reports for this device; peer average 2.46/device2024-02: 0 reports for this device; peer average 2.19/device2024-03: 0 reports for this device; peer average 3.78/device2024-04: 0 reports for this device; peer average 1.75/device2024-05: 0 reports for this device; peer average 3.48/device2024-06: 0 reports for this device; peer average 2.22/device2024-07: 0 reports for this device; peer average 1.88/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2.69/device2024-10: 0 reports for this device; peer average 2.09/device2024-11: 0 reports for this device; peer average 2.18/device2024-12: 0 reports for this device; peer average 1.85/device2025-01: 0 reports for this device; peer average 2.26/device2025-02: 0 reports for this device; peer average 2.5/device2025-03: 0 reports for this device; peer average 2.37/device2025-04: 0 reports for this device; peer average 2.37/device2025-05: 0 reports for this device; peer average 2.3/device2025-06: 0 reports for this device; peer average 2.13/device2025-07: 0 reports for this device; peer average 2.01/device2025-08: 0 reports for this device; peer average 1.93/device2025-09: 0 reports for this device; peer average 1.88/device2025-10: 0 reports for this device; peer average 1.96/device2025-11: 0 reports for this device; peer average 1.97/device2025-12: 0 reports for this device; peer average 2.35/device2026-01: 0 reports for this device; peer average 2.42/device2026-02: 0 reports for this device; peer average 2.43/device2026-03: 0 reports for this device; peer average 2.48/device2026-04: 0 reports for this device; peer average 1.86/device2026-05: 0 reports for this device; peer average 2.01/device2026-06: 0 reports for this device; peer average 4.47/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
2019-0201.95
2019-0301.98
2019-0402.02
2019-0502.28
2019-0602.56
2019-0701.67
2019-0802.81
2019-0901.75
2019-1001.88
2019-1102.26
2019-1201.63
2020-0102.38
2020-0202.24
2020-0302.23
2020-0401.58
2020-0502.36
2020-0601.86
2020-0701.85
2020-0801.94
2020-0902.39
2020-1002.58
2020-1102.33
2020-1202.03
2021-0102.25
2021-0201.86
2021-0302.44
2021-0402.26
2021-0501.99
2021-0601.95
2021-0706.61
2021-0801.95
2021-0901.76
2021-1002.52
2021-1102.25
2021-1202.3
2022-0102.13
2022-0201.96
2022-0301.84
2022-0402
2022-0501.8
2022-0602
2022-0703.96
2022-0801.87
2022-0902.71
2022-1001.46
2022-1101.78
2022-1202.08
2023-0101.71
2023-0201.78
2023-0301.78
2023-0401.98
2023-0501.56
2023-0601.74
2023-0701.91
2023-0801.64
2023-0902.73
2023-1002.68
2023-1102.54
2023-1201.68
2024-0102.46
2024-0202.19
2024-0303.78
2024-0401.75
2024-0503.48
2024-0602.22
2024-0701.88
2024-0802
2024-0902.69
2024-1002.09
2024-1102.18
2024-1201.85
2025-0102.26
2025-0202.5
2025-0302.37
2025-0402.37
2025-0502.3
2025-0602.13
2025-0702.01
2025-0801.93
2025-0901.88
2025-1001.96
2025-1101.97
2025-1202.35
2026-0102.42
2026-0202.43
2026-0302.48
2026-0401.86
2026-0502.01
2026-0604.47
This device (reports/month)Average device in KWP, MNH, MNI, NKB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091797 — cites (transitively): K043151 (d1), K052054 (d1), K081080 (d1) — cited as predicate by K101790, K133153

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