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PedFuse
Model 01-80206 · SPINEFRONTIER, INC. · DI 00190361035374
MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070
MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070
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
2.08
2019-02
0
1.89
2019-03
0
2.06
2019-04
0
2
2019-05
0
2.31
2019-06
0
2.72
2019-07
0
1.69
2019-08
0
2.87
2019-09
0
1.72
2019-10
0
1.87
2019-11
0
2.24
2019-12
0
1.69
2020-01
0
2.37
2020-02
0
2.2
2020-03
0
2.08
2020-04
0
1.67
2020-05
0
2.29
2020-06
0
1.87
2020-07
0
1.8
2020-08
0
1.92
2020-09
0
2.5
2020-10
0
2.57
2020-11
0
2.36
2020-12
0
2.05
2021-01
0
2.26
2021-02
0
1.86
2021-03
0
2.5
2021-04
0
2.31
2021-05
0
2
2021-06
0
1.72
2021-07
0
7.73
2021-08
0
1.94
2021-09
0
1.68
2021-10
0
2.66
2021-11
0
2.37
2021-12
0
2.38
2022-01
0
2.15
2022-02
0
1.9
2022-03
0
1.89
2022-04
0
2.13
2022-05
0
1.8
2022-06
0
1.99
2022-07
0
3.89
2022-08
0
1.91
2022-09
0
2.75
2022-10
0
1.4
2022-11
0
1.96
2022-12
0
2.04
2023-01
0
1.61
2023-02
0
1.73
2023-03
0
1.88
2023-04
0
2
2023-05
0
1.55
2023-06
0
1.78
2023-07
0
1.93
2023-08
0
1.49
2023-09
0
2.9
2023-10
0
2.86
2023-11
0
2.87
2023-12
0
1.68
2024-01
0
2.5
2024-02
0
2.15
2024-03
0
3.98
2024-04
0
1.8
2024-05
0
3.43
2024-06
0
1.63
2024-07
0
1.9
2024-08
0
2.14
2024-09
0
1.96
2024-10
0
1.77
2024-11
0
2.39
2024-12
0
1.72
2025-01
0
2.18
2025-02
0
2.41
2025-03
0
2.5
2025-04
0
2.45
2025-05
0
1.84
2025-06
0
1.81
2025-07
0
2.26
2025-08
0
1.82
2025-09
0
1.94
2025-10
0
2.1
2025-11
0
1.92
2025-12
0
2.18
2026-01
0
2.54
2026-02
0
2.46
2026-03
0
2.64
2026-04
0
1.84
2026-05
0
1.63
2026-06
0
5.13
This device (reports/month)Average device in MNH, MNI (reports/device/month)