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STRYKER NAV3
Model 7700-700-000 · Stryker Leibinger GmbH & Co. KG · DI 04546540696427
HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 (4)
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: 4
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
9.11
2019-02
0
9.71
2019-03
0
9.79
2019-04
1
11.87
2019-05
0
13.04
2019-06
0
13.02
2019-07
0
9.88
2019-08
0
7.49
2019-09
1
7.85
2019-10
0
7.27
2019-11
0
9.91
2019-12
0
10.08
2020-01
0
8.04
2020-02
0
9.15
2020-03
0
9.62
2020-04
0
9.53
2020-05
0
11.43
2020-06
0
8.71
2020-07
0
9.7
2020-08
0
8.58
2020-09
0
8.91
2020-10
0
9.9
2020-11
0
10.94
2020-12
0
9.27
2021-01
0
9.05
2021-02
0
9.77
2021-03
0
9.35
2021-04
0
8.9
2021-05
0
9.8
2021-06
0
11.37
2021-07
0
8.74
2021-08
0
10.53
2021-09
0
13
2021-10
0
8.34
2021-11
0
11.01
2021-12
0
7.44
2022-01
0
6.82
2022-02
0
7.95
2022-03
0
9.35
2022-04
2
6.39
2022-05
0
8.87
2022-06
0
9.36
2022-07
0
8.79
2022-08
0
8.72
2022-09
0
8.74
2022-10
0
11.56
2022-11
0
10.32
2022-12
0
10.44
2023-01
0
9.14
2023-02
0
8.45
2023-03
0
10.04
2023-04
0
10.25
2023-05
0
10.82
2023-06
0
12.34
2023-07
0
14.14
2023-08
0
13.16
2023-09
0
11.4
2023-10
0
10.8
2023-11
0
14.61
2023-12
0
12.27
2024-01
0
16.51
2024-02
0
12.43
2024-03
0
14.98
2024-04
0
13.44
2024-05
0
12.95
2024-06
0
12.52
2024-07
0
13.91
2024-08
0
18.98
2024-09
0
14.7
2024-10
0
18.36
2024-11
0
10.72
2024-12
0
10.63
2025-01
0
12.32
2025-02
0
13.73
2025-03
0
12.56
2025-04
0
13.77
2025-05
0
13.22
2025-06
0
16.69
2025-07
0
12.44
2025-08
0
10.63
2025-09
0
11.02
2025-10
0
10.7
2025-11
0
9.45
2025-12
0
8.85
2026-01
0
10.24
2026-02
0
8.24
2026-03
0
8.88
2026-04
0
7.34
2026-05
0
7.59
2026-06
0
5.85
This device (reports/month)Average device in HAW, OLO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
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