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INFINITY™ Occipitocervical Upper Thoracic System

Model G3600412 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00643169543010

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

NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075

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.

24682019-01: 0 reports for this device; peer average 2.08/device2019-02: 0 reports for this device; peer average 1.9/device2019-03: 0 reports for this device; peer average 1.9/device2019-04: 0 reports for this device; peer average 2.09/device2019-05: 0 reports for this device; peer average 2.08/device2019-06: 0 reports for this device; peer average 2.2/device2019-07: 0 reports for this device; peer average 1.63/device2019-08: 0 reports for this device; peer average 2.42/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 1.77/device2019-11: 0 reports for this device; peer average 2.07/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 0 reports for this device; peer average 2.69/device2020-02: 0 reports for this device; peer average 2.46/device2020-03: 0 reports for this device; peer average 2.51/device2020-04: 0 reports for this device; peer average 1.44/device2020-05: 0 reports for this device; peer average 2.08/device2020-06: 0 reports for this device; peer average 2.19/device2020-07: 0 reports for this device; peer average 1.69/device2020-08: 0 reports for this device; peer average 1.76/device2020-09: 0 reports for this device; peer average 2.04/device2020-10: 0 reports for this device; peer average 2.3/device2020-11: 0 reports for this device; peer average 2.14/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 2.05/device2021-02: 0 reports for this device; peer average 1.92/device2021-03: 0 reports for this device; peer average 2.19/device2021-04: 0 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 1.95/device2021-06: 0 reports for this device; peer average 1.94/device2021-07: 0 reports for this device; peer average 8.17/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.29/device2021-11: 0 reports for this device; peer average 1.86/device2021-12: 0 reports for this device; peer average 1.97/device2022-01: 0 reports for this device; peer average 2.03/device2022-02: 0 reports for this device; peer average 1.87/device2022-03: 0 reports for this device; peer average 1.72/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 1.66/device2022-06: 0 reports for this device; peer average 2.06/device2022-07: 0 reports for this device; peer average 2.98/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 2.84/device2022-10: 0 reports for this device; peer average 1.49/device2022-11: 0 reports for this device; peer average 1.83/device2022-12: 0 reports for this device; peer average 1.98/device2023-01: 0 reports for this device; peer average 1.78/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2.04/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 1.61/device2023-07: 0 reports for this device; peer average 1.77/device2023-08: 0 reports for this device; peer average 1.47/device2023-09: 0 reports for this device; peer average 2.61/device2023-10: 0 reports for this device; peer average 2.37/device2023-11: 0 reports for this device; peer average 2.09/device2023-12: 0 reports for this device; peer average 1.55/device2024-01: 0 reports for this device; peer average 2.38/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 3.58/device2024-04: 0 reports for this device; peer average 1.69/device2024-05: 0 reports for this device; peer average 3.28/device2024-06: 0 reports for this device; peer average 2.21/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 2.44/device2024-10: 0 reports for this device; peer average 2.36/device2024-11: 0 reports for this device; peer average 1.85/device2024-12: 0 reports for this device; peer average 1.78/device2025-01: 0 reports for this device; peer average 2.41/device2025-02: 0 reports for this device; peer average 2.37/device2025-03: 0 reports for this device; peer average 2.08/device2025-04: 0 reports for this device; peer average 2.13/device2025-05: 0 reports for this device; peer average 2.42/device2025-06: 0 reports for this device; peer average 2.59/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.92/device2025-09: 0 reports for this device; peer average 1.89/device2025-10: 0 reports for this device; peer average 1.98/device2025-11: 0 reports for this device; peer average 1.99/device2025-12: 0 reports for this device; peer average 2.3/device2026-01: 0 reports for this device; peer average 2.53/device2026-02: 0 reports for this device; peer average 2.41/device2026-03: 0 reports for this device; peer average 2.43/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 2.34/device2026-06: 0 reports for this device; peer average 4.01/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.08
2019-0201.9
2019-0301.9
2019-0402.09
2019-0502.08
2019-0602.2
2019-0701.63
2019-0802.42
2019-0901.86
2019-1001.77
2019-1102.07
2019-1201.55
2020-0102.69
2020-0202.46
2020-0302.51
2020-0401.44
2020-0502.08
2020-0602.19
2020-0701.69
2020-0801.76
2020-0902.04
2020-1002.3
2020-1102.14
2020-1202.07
2021-0102.05
2021-0201.92
2021-0302.19
2021-0402.02
2021-0501.95
2021-0601.94
2021-0708.17
2021-0802
2021-0901.72
2021-1002.29
2021-1101.86
2021-1201.97
2022-0102.03
2022-0201.87
2022-0301.72
2022-0401.76
2022-0501.66
2022-0602.06
2022-0702.98
2022-0802.07
2022-0902.84
2022-1001.49
2022-1101.83
2022-1201.98
2023-0101.78
2023-0201.96
2023-0302
2023-0402.04
2023-0502.02
2023-0601.61
2023-0701.77
2023-0801.47
2023-0902.61
2023-1002.37
2023-1102.09
2023-1201.55
2024-0102.38
2024-0202.08
2024-0303.58
2024-0401.69
2024-0503.28
2024-0602.21
2024-0701.9
2024-0801.83
2024-0902.44
2024-1002.36
2024-1101.85
2024-1201.78
2025-0102.41
2025-0202.37
2025-0302.08
2025-0402.13
2025-0502.42
2025-0602.59
2025-0701.83
2025-0801.92
2025-0901.89
2025-1001.98
2025-1101.99
2025-1202.3
2026-0102.53
2026-0202.41
2026-0302.43
2026-0401.8
2026-0502.34
2026-0604.01
This device (reports/month)Average device in KWP, NKG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K163375 — cites (transitively): K003780 (d1), K052734 (d1), K070742 (d1), K071942 (d1), K082728 (d1), K090714 (d1), K091365 (d1), K123656 (d1), K123906 (d1), K143471 (d1), K152338 (d1), K162379 (d1), K042789 (d2), K080805 (d2), K083071 (d2), K121191 (d2), K062254 (d2), K123568 (d2), K022015 (d2), K042498 (d2), K052376 (d2), K052402 (d2), K031833 (d2), K102555 (d2), K113174 (d2), K152457 (d2), K023555 (d3), K062728 (d3), K142591 (d3), K142847 (d3), K031655 (d4), K042025 (d4), K052187 (d4), K141494 (d4), K091974 (d5), K140276 (d5), K091445 (d6), K111457 (d6), K132328 (d6), K132471 (d6), K050439 (d7), K090390 (d7), K101074 (d7), K981676 (d7), K040962 (d8), K050981 (d8) — cited as predicate by K173338, K180851, K181111, K210449, K220810, K223764, K253129, K254045, K254165

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