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Medtronic Transportation/Sterilization Cassette

Model 5332021 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00643169792005

KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · Class II · 21 CFR 880.6850

UDILibrary device dossier · generated 2026-09-11 · 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.

71421282019-03: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 10/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 3/device2020-03: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 28/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 6/device2021-03: 0 reports for this device; peer average 2.4/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3.5/device2021-07: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 6/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3/device2022-02: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 13.5/device2023-12: 0 reports for this device; peer average 18/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 9/device2024-07: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 3/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 3/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 12.5/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 4.5/device2025-05: 0 reports for this device; peer average 3.33/device2025-06: 0 reports for this device; peer average 11/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 5.67/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 3.67/device2026-02: 0 reports for this device; peer average 3.33/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2.5/device2026-06: 0 reports for this device; peer average 3.67/device0305060709110203061112010203050607091011120205061004050607111201020305060709101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-05010
2019-0604
2019-0703
2019-0903
2019-1102
2020-0203
2020-0301.5
2020-0601
2020-1102
2020-12028
2021-0102
2021-0206
2021-0302.4
2021-0503
2021-0603.5
2021-0703
2021-0903
2021-1006
2021-1103
2021-1203
2022-0201
2022-0506
2022-0601.5
2022-1002
2023-0403
2023-0504.5
2023-0603
2023-0701
2023-11013.5
2023-12018
2024-0101
2024-0202
2024-0301
2024-0502
2024-0609
2024-0702
2024-0903
2024-1001
2024-1103
2024-1201
2025-01012.5
2025-0202
2025-0302
2025-0404.5
2025-0503.33
2025-06011
2025-0701
2025-0805.67
2025-0901
2025-1001.67
2025-1104
2025-1201.5
2026-0103.67
2026-0203.33
2026-0301
2026-0401
2026-0502.5
2026-0603.67
This device (reports/month)Average device in KCT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K162379 — cites (transitively): K031833 (d1), K102555 (d1), K113174 (d1), K152457 (d1), K142591 (d2), K142847 (d2), K031655 (d3), K042025 (d3), K052187 (d3), K141494 (d3), K091974 (d4), K140276 (d4), K091445 (d5), K111457 (d5), K132328 (d5), K132471 (d5), K050439 (d6), K090390 (d6), K101074 (d6), K981676 (d6), K040962 (d7), K050981 (d7) — cited as predicate by K163375, K170679, K181139, K182436, K202328, K223494

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