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Unnamed device

Model 78-30020 · Stryker Leibinger GmbH & Co. KG · DI 07613252599647

JEY — Plate, Bone · Class II · 21 CFR 872.4760

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 (9)

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.

Injury: 5 · Malfunction: 4

23572019-01: 0 reports for this device; peer average 1.41/device2019-02: 2 reports for this device; peer average 1.33/device2019-03: 2 reports for this device; peer average 2.41/device2019-04: 0 reports for this device; peer average 2.95/device2019-05: 0 reports for this device; peer average 3.31/device2019-06: 0 reports for this device; peer average 1.41/device2019-07: 0 reports for this device; peer average 1.76/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.17/device2019-10: 1 reports for this device; peer average 2.53/device2019-11: 0 reports for this device; peer average 1.72/device2019-12: 0 reports for this device; peer average 2.35/device2020-01: 1 reports for this device; peer average 2.54/device2020-02: 0 reports for this device; peer average 1.83/device2020-03: 0 reports for this device; peer average 2.06/device2020-04: 0 reports for this device; peer average 2.13/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.06/device2020-10: 0 reports for this device; peer average 2.22/device2020-11: 0 reports for this device; peer average 1.71/device2020-12: 1 reports for this device; peer average 1.9/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 1.25/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 3.33/device2021-05: 0 reports for this device; peer average 4.09/device2021-06: 0 reports for this device; peer average 1.93/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 0 reports for this device; peer average 3.31/device2021-09: 0 reports for this device; peer average 1.58/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 3.93/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 3.5/device2022-04: 0 reports for this device; peer average 2.36/device2022-05: 0 reports for this device; peer average 1.77/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.16/device2022-08: 0 reports for this device; peer average 2.15/device2022-09: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 6.64/device2022-11: 0 reports for this device; peer average 2.27/device2022-12: 0 reports for this device; peer average 3.37/device2023-01: 0 reports for this device; peer average 2.67/device2023-02: 0 reports for this device; peer average 3.26/device2023-03: 0 reports for this device; peer average 2.67/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 4.15/device2023-07: 0 reports for this device; peer average 3.81/device2023-08: 0 reports for this device; peer average 3.07/device2023-09: 0 reports for this device; peer average 2.58/device2023-10: 0 reports for this device; peer average 1.44/device2023-11: 1 reports for this device; peer average 2.68/device2023-12: 0 reports for this device; peer average 2.05/device2024-01: 0 reports for this device; peer average 2.89/device2024-02: 0 reports for this device; peer average 2.67/device2024-03: 0 reports for this device; peer average 2.23/device2024-04: 1 reports for this device; peer average 2.61/device2024-05: 0 reports for this device; peer average 2.29/device2024-06: 0 reports for this device; peer average 1.83/device2024-07: 0 reports for this device; peer average 1.55/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 2.29/device2024-11: 0 reports for this device; peer average 2.75/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.38/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.9/device2025-05: 0 reports for this device; peer average 2.27/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 2.57/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.95/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 4.38/device2026-01: 0 reports for this device; peer average 1.57/device2026-02: 0 reports for this device; peer average 2.45/device2026-03: 0 reports for this device; peer average 1.11/device2026-04: 0 reports for this device; peer average 3.09/device2026-05: 0 reports for this device; peer average 2.1/device2026-06: 0 reports for this device; peer average 3.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.41
2019-0221.33
2019-0322.41
2019-0402.95
2019-0503.31
2019-0601.41
2019-0701.76
2019-0802
2019-0902.17
2019-1012.53
2019-1101.72
2019-1202.35
2020-0112.54
2020-0201.83
2020-0302.06
2020-0402.13
2020-0502.31
2020-0602
2020-0702.17
2020-0802.21
2020-0902.06
2020-1002.22
2020-1101.71
2020-1211.9
2021-0102.13
2021-0201.25
2021-0302
2021-0403.33
2021-0504.09
2021-0601.93
2021-0701.33
2021-0803.31
2021-0901.58
2021-1002.12
2021-1102
2021-1203.93
2022-0102
2022-0202.67
2022-0303.5
2022-0402.36
2022-0501.77
2022-0602.5
2022-0702.16
2022-0802.15
2022-0901.5
2022-1006.64
2022-1102.27
2022-1203.37
2023-0102.67
2023-0203.26
2023-0302.67
2023-0401.5
2023-0502.88
2023-0604.15
2023-0703.81
2023-0803.07
2023-0902.58
2023-1001.44
2023-1112.68
2023-1202.05
2024-0102.89
2024-0202.67
2024-0302.23
2024-0412.61
2024-0502.29
2024-0601.83
2024-0701.55
2024-0801.6
2024-0902.07
2024-1002.29
2024-1102.75
2024-1201.7
2025-0101.5
2025-0201.38
2025-0302
2025-0401.9
2025-0502.27
2025-0602
2025-0704.1
2025-0802.57
2025-0901.69
2025-1001.95
2025-1101.53
2025-1204.38
2026-0101.57
2026-0202.45
2026-0301.11
2026-0403.09
2026-0502.1
2026-0603.56
This device (reports/month)Average device in JEY (reports/device/month)

Regulatory clearances

  • K222650 SESE 2022-12-09 (k number procode)
  • K193136 SESE 2020-03-26 (k number procode)
  • K132519 SESE 2013-12-06 (k number procode)

Predicate lineage

K132519 — cites (transitively): K014263 (d1) — cited as predicate by K182305, K190696, K193136, K193280

K193136 — cites (transitively): K132519 (d1), K192192 (d1), K014263 (d2), K133907 (d2) — cited as predicate by K222650

K222650 — cites (transitively): K014263 (d1), K190696 (d1), K193136 (d1), K132519 (d2), K192192 (d2), K133907 (d3)

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

Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG

  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations