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AccuShape
Model ZB-SPK104 · Medcad · DI 00810007631721
GXN — Plate, Cranioplasty, Preformed, Non-Alterable · Class II · 21 CFR 882.5330
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
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.
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
3.5
2019-02
0
8.73
2019-03
0
4.93
2019-04
0
6.27
2019-05
0
11
2019-06
0
8.36
2019-07
0
7.5
2019-08
0
21.43
2019-09
0
6.31
2019-10
0
5.2
2019-11
0
6.67
2019-12
0
10.5
2020-01
0
3.15
2020-02
0
7.93
2020-03
0
8.2
2020-04
0
11.09
2020-05
0
5.38
2020-06
0
2.42
2020-07
0
2.87
2020-08
0
3.11
2020-09
0
1.88
2020-10
0
2.92
2020-11
0
2.36
2020-12
0
3
2021-01
0
2.75
2021-02
0
2.69
2021-03
0
3.46
2021-04
0
3.5
2021-05
0
4
2021-06
0
3.12
2021-07
0
4.07
2021-08
0
3.87
2021-09
0
2.44
2021-10
0
3.36
2021-11
0
3.25
2021-12
0
3.85
2022-01
0
3
2022-02
0
2.61
2022-03
0
3.46
2022-04
0
2
2022-05
0
1.67
2022-06
0
3.75
2022-07
0
2.85
2022-08
0
2.4
2022-09
0
2.91
2022-10
0
3
2022-11
0
2.17
2022-12
0
2.11
2023-01
0
2.21
2023-02
0
2.42
2023-03
0
2.37
2023-04
0
2.32
2023-05
0
1.53
2023-06
0
2.75
2023-07
0
2.76
2023-08
0
2.11
2023-09
0
2
2023-10
0
3.38
2023-11
0
2.1
2023-12
0
1.83
2024-01
0
2.13
2024-02
0
2.65
2024-03
0
2.58
2024-04
0
4.53
2024-05
0
2.62
2024-06
0
2.56
2024-07
0
2.86
2024-08
0
3.17
2024-09
0
3
2024-10
0
3.09
2024-11
0
3.1
2024-12
0
2.26
2025-01
0
6.46
2025-02
0
6.44
2025-03
0
2.6
2025-04
0
2.36
2025-05
0
2.5
2025-06
0
2.89
2025-07
0
3
2025-08
0
3.76
2025-09
0
2.78
2025-10
0
9.19
2025-11
0
3.08
2025-12
0
6.56
2026-01
0
7.11
2026-02
0
4.33
2026-03
0
15.42
2026-04
0
11.71
2026-05
0
18.7
2026-06
0
10
This device (reports/month)Average device in GXN, LLZ (reports/device/month)