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UNIVERSAL NEURO 3
Model 92-34620 · Stryker Leibinger GmbH & Co. KG · DI 07613327123357
GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250
UDILibrary device dossier · generated 2026-09-12 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.5
2019-02
0
1
2019-03
0
2.71
2019-04
0
1.5
2019-05
0
2
2019-06
0
1.29
2019-07
0
1.75
2019-08
0
2.5
2019-09
0
1.83
2019-10
0
2
2019-11
0
2.5
2019-12
0
7
2020-01
0
2.25
2020-02
0
1.83
2020-03
0
2.8
2020-04
0
2.2
2020-05
0
2.22
2020-06
0
2.78
2020-07
0
2.67
2020-08
0
1.9
2020-09
0
4
2020-10
0
2.25
2020-11
0
2.14
2020-12
0
2.33
2021-01
0
2
2021-02
0
2.5
2021-03
0
3.67
2021-04
0
3.8
2021-05
0
2.4
2021-06
0
2.5
2021-07
0
1.17
2021-08
0
2.67
2021-09
0
2
2021-10
0
2.86
2021-11
0
1.8
2021-12
0
2.86
2022-01
0
2.67
2022-02
0
6.25
2022-03
0
4.67
2022-04
0
1.25
2022-05
0
1.67
2022-06
0
5.33
2022-07
0
1.5
2022-08
0
2
2022-09
0
1.5
2022-10
0
1
2022-11
0
1.33
2022-12
0
3.91
2023-01
0
3
2023-02
0
2
2023-03
0
4.75
2023-04
0
1.67
2023-05
0
1
2023-06
0
9.4
2023-07
0
1.8
2023-08
0
2.33
2023-09
0
2.75
2023-10
0
2
2023-11
0
5.5
2023-12
0
1.4
2024-01
0
4.67
2024-02
0
3
2024-03
0
4
2024-04
0
3.25
2024-05
0
1.5
2024-06
0
2
2024-07
0
1
2024-08
0
1.4
2024-09
0
4
2024-10
0
4.5
2024-11
0
3.5
2024-12
0
1.67
2025-01
0
1.67
2025-03
0
2.5
2025-04
0
3.5
2025-05
0
3
2025-06
0
3
2025-07
0
4.5
2025-08
0
1.5
2025-10
0
1.5
2025-11
0
1
2025-12
0
6.5
2026-01
0
2.17
2026-02
0
3
2026-03
0
1
2026-04
0
8
2026-05
0
3.4
2026-06
0
7.5
This device (reports/month)Average device in GXR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K112557 — cites (transitively): K022012 (d1), K944561 (d1), K944565 (d1), K983528 (d1) — cited as predicate by K151387, K192162
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