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Kyocera Medical Technologies, Inc.

Model Tesera · KYOCERA MEDICAL TECHNOLOGIES, INC. · DI 00841523100019

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar · Class II · 21 CFR 888.3080

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 (2)

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.

Malfunction: 2

13452019-01: 0 reports for this device; peer average 1.33/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.14/device2019-05: 0 reports for this device; peer average 1.33/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.25/device2019-09: 0 reports for this device; peer average 3/device2019-10: 0 reports for this device; peer average 4/device2019-11: 0 reports for this device; peer average 1.4/device2019-12: 0 reports for this device; peer average 1.83/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2.4/device2020-03: 0 reports for this device; peer average 1.69/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.4/device2020-06: 0 reports for this device; peer average 4.5/device2020-07: 0 reports for this device; peer average 4.8/device2020-08: 0 reports for this device; peer average 1.33/device2020-09: 0 reports for this device; peer average 5/device2020-10: 0 reports for this device; peer average 2.63/device2020-11: 0 reports for this device; peer average 3.38/device2020-12: 0 reports for this device; peer average 1.29/device2021-01: 0 reports for this device; peer average 2.67/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.82/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2.71/device2021-06: 0 reports for this device; peer average 2.78/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2.86/device2021-09: 0 reports for this device; peer average 1.7/device2021-10: 0 reports for this device; peer average 2.71/device2021-11: 0 reports for this device; peer average 2.33/device2021-12: 2 reports for this device; peer average 3.13/device2022-01: 0 reports for this device; peer average 3.67/device2022-02: 0 reports for this device; peer average 3.71/device2022-03: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 2.63/device2022-06: 0 reports for this device; peer average 1.56/device2022-07: 0 reports for this device; peer average 1.89/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 1.75/device2022-11: 0 reports for this device; peer average 1.57/device2022-12: 0 reports for this device; peer average 1.62/device2023-01: 0 reports for this device; peer average 1.75/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 1.78/device2023-04: 0 reports for this device; peer average 2.11/device2023-05: 0 reports for this device; peer average 1.43/device2023-06: 0 reports for this device; peer average 1.33/device2023-07: 0 reports for this device; peer average 1.8/device2023-08: 0 reports for this device; peer average 1.62/device2023-09: 0 reports for this device; peer average 1.67/device2023-10: 0 reports for this device; peer average 1.29/device2023-11: 0 reports for this device; peer average 2.33/device2023-12: 0 reports for this device; peer average 1.33/device2024-01: 0 reports for this device; peer average 1.91/device2024-02: 0 reports for this device; peer average 1.83/device2024-03: 0 reports for this device; peer average 1.64/device2024-04: 0 reports for this device; peer average 2.33/device2024-05: 0 reports for this device; peer average 2.33/device2024-06: 0 reports for this device; peer average 1.86/device2024-07: 0 reports for this device; peer average 2.14/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.79/device2024-10: 0 reports for this device; peer average 1.86/device2024-11: 0 reports for this device; peer average 1.83/device2024-12: 0 reports for this device; peer average 2.57/device2025-01: 0 reports for this device; peer average 1.4/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.55/device2025-04: 0 reports for this device; peer average 1.57/device2025-05: 0 reports for this device; peer average 1.6/device2025-06: 0 reports for this device; peer average 1.67/device2025-07: 0 reports for this device; peer average 2.8/device2025-08: 0 reports for this device; peer average 1.57/device2025-09: 0 reports for this device; peer average 2.11/device2025-10: 0 reports for this device; peer average 1.75/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.73/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.36/device2026-03: 0 reports for this device; peer average 2.25/device2026-04: 0 reports for this device; peer average 1.7/device2026-05: 0 reports for this device; peer average 1.56/device2026-06: 0 reports for this device; peer average 1.73/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0202
2019-0302
2019-0401.14
2019-0501.33
2019-0601.86
2019-0701.44
2019-0801.25
2019-0903
2019-1004
2019-1101.4
2019-1201.83
2020-0102
2020-0202.4
2020-0301.69
2020-0401
2020-0501.4
2020-0604.5
2020-0704.8
2020-0801.33
2020-0905
2020-1002.63
2020-1103.38
2020-1201.29
2021-0102.67
2021-0202
2021-0301.82
2021-0402
2021-0502.71
2021-0602.78
2021-0703
2021-0802.86
2021-0901.7
2021-1002.71
2021-1102.33
2021-1223.13
2022-0103.67
2022-0203.71
2022-0302
2022-0401.75
2022-0502.63
2022-0601.56
2022-0701.89
2022-0803
2022-0902.29
2022-1001.75
2022-1101.57
2022-1201.62
2023-0101.75
2023-0201.5
2023-0301.78
2023-0402.11
2023-0501.43
2023-0601.33
2023-0701.8
2023-0801.62
2023-0901.67
2023-1001.29
2023-1102.33
2023-1201.33
2024-0101.91
2024-0201.83
2024-0301.64
2024-0402.33
2024-0502.33
2024-0601.86
2024-0702.14
2024-0801.83
2024-0901.79
2024-1001.86
2024-1101.83
2024-1202.57
2025-0101.4
2025-0201.5
2025-0301.55
2025-0401.57
2025-0501.6
2025-0601.67
2025-0702.8
2025-0801.57
2025-0902.11
2025-1001.75
2025-1101
2025-1201.73
2026-0101
2026-0201.36
2026-0302.25
2026-0401.7
2026-0501.56
2026-0601.73
This device (reports/month)Average device in OVD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K131122 — cites (transitively): K082260 (d1), K083815 (d1) — cited as predicate by K153250, K153720, K180502, K181655, K193320, K212980, K230808

K140106 — cited as predicate by K142095, K153250, K180502, K181591, K181655, K193320, K212980

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — KYOCERA MEDICAL TECHNOLOGIES, INC.

  • NAI 2021-08-19 Kyocera Medical Technologies, Inc · 0 citations
  • NAI 2021-08-19 Kyocera Medical Technologies, Inc · 0 citations
  • OAI 2016-02-04 Kyocera Medical Technologies, Inc · 0 citations
  • OAI 2016-02-04 Kyocera Medical Technologies, Inc · 0 citations
  • OAI 2015-02-13 Kyocera Medical Technologies, Inc · 5 citations
  • OAI 2015-02-13 Kyocera Medical Technologies, Inc · 5 citations
  • NAI 2012-02-09 Kyocera Medical Technologies, Inc · 0 citations
  • NAI 2012-02-09 Kyocera Medical Technologies, Inc · 0 citations