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SFS;SFS LE;SFS SCOLI
Model 56-3450 · Orthofix US LLC · DI 18257200055555
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
2.07
2019-02
0
1.9
2019-03
0
2.06
2019-04
0
1.97
2019-05
0
2.24
2019-06
0
2.66
2019-07
0
1.66
2019-08
0
2.79
2019-09
0
1.72
2019-10
0
1.86
2019-11
0
2.2
2019-12
0
1.75
2020-01
0
2.31
2020-02
0
2.27
2020-03
0
2.08
2020-04
0
1.66
2020-05
0
2.25
2020-06
0
1.85
2020-07
0
1.78
2020-08
0
1.92
2020-09
0
2.68
2020-10
0
2.55
2020-11
0
2.36
2020-12
0
2.03
2021-01
0
2.26
2021-02
0
1.85
2021-03
0
2.46
2021-04
0
2.32
2021-05
0
2.05
2021-06
0
1.69
2021-07
0
7.6
2021-08
0
1.95
2021-09
0
1.68
2021-10
0
2.59
2021-11
0
2.29
2021-12
0
2.36
2022-01
0
2.09
2022-02
0
1.89
2022-03
0
1.93
2022-04
0
2.14
2022-05
0
1.79
2022-06
0
1.98
2022-07
0
3.86
2022-08
0
1.91
2022-09
0
2.71
2022-10
0
1.4
2022-11
0
1.96
2022-12
0
2.02
2023-01
0
1.67
2023-02
0
1.71
2023-03
0
1.92
2023-04
0
2
2023-05
0
1.54
2023-06
0
1.79
2023-07
0
1.97
2023-08
0
1.56
2023-09
0
2.87
2023-10
0
2.87
2023-11
0
2.8
2023-12
0
1.74
2024-01
0
2.5
2024-02
0
2.13
2024-03
0
3.94
2024-04
0
1.8
2024-05
0
3.4
2024-06
0
1.61
2024-07
0
1.91
2024-08
0
2.1
2024-09
0
1.98
2024-10
0
1.77
2024-11
0
2.37
2024-12
0
1.72
2025-01
0
2.17
2025-02
0
2.43
2025-03
0
2.49
2025-04
0
2.45
2025-05
0
1.84
2025-06
0
1.81
2025-07
0
2.75
2025-08
0
1.79
2025-09
0
1.94
2025-10
0
2.08
2025-11
0
1.89
2025-12
0
2.14
2026-01
0
2.51
2026-02
0
2.41
2026-03
0
2.62
2026-04
0
1.82
2026-05
0
1.65
2026-06
0
5.06
This device (reports/month)Average device in MNI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080407 — cited as predicate by K093926, K100044, K140260, K150184, K170647, K171082, K211710
Lineage extracted from public 510(k) summary text (heuristic).