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130 DEG EXT FEM NECK FIX PLATE, 3-HOLE
Model 324-31303 · Osteocentric Technologies, Inc. · DI 00810189110274
KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-07 · 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
1.48
2019-02
0
1.46
2019-03
0
1.35
2019-04
0
2
2019-05
0
1.33
2019-06
0
1.62
2019-07
0
2.13
2019-08
0
1.62
2019-09
0
1.45
2019-10
0
1.25
2019-11
0
1.33
2019-12
0
1.35
2020-01
0
1.6
2020-02
0
2.41
2020-03
0
1.43
2020-04
0
1.5
2020-05
0
1
2020-06
0
1.96
2020-07
0
1.5
2020-08
0
2.08
2020-09
0
2.38
2020-10
0
2.43
2020-11
0
1.72
2020-12
0
2.23
2021-01
0
1.6
2021-02
0
2.68
2021-03
0
2.64
2021-04
0
2.51
2021-05
0
2.82
2021-06
0
1.95
2021-07
0
1.71
2021-08
0
1.62
2021-09
0
1.76
2021-10
0
1.52
2021-11
0
2.83
2021-12
0
1.63
2022-01
0
2
2022-02
0
2.71
2022-03
0
2.12
2022-04
0
2.33
2022-05
0
4.67
2022-06
0
2.31
2022-07
0
2.1
2022-08
0
2.08
2022-09
0
2.52
2022-10
0
3
2022-11
0
3.44
2022-12
0
2.44
2023-01
0
2.92
2023-02
0
2.15
2023-03
0
2.15
2023-04
0
2.31
2023-05
0
3.16
2023-06
0
2.14
2023-07
0
2.17
2023-08
0
1.46
2023-09
0
2.25
2023-10
0
1.2
2023-11
0
1.25
2023-12
0
1.33
2024-01
0
1.2
2024-02
0
2.17
2024-03
0
1.35
2024-04
0
1.83
2024-05
0
1.43
2024-06
0
1.45
2024-07
0
1.1
2024-08
0
1.64
2024-09
0
1.25
2024-10
0
2
2024-11
0
1.67
2024-12
0
4.25
2025-01
0
1.29
2025-02
0
1.62
2025-03
0
1.25
2025-04
0
2
2025-05
0
1.44
2025-06
0
1.26
2025-07
0
1.73
2025-08
0
1.24
2025-09
0
1.54
2025-10
0
2.56
2025-11
0
1.86
2025-12
0
1.8
2026-01
0
1.57
2026-02
0
1.22
2026-03
0
1.25
2026-04
0
1.5
2026-05
0
3.33
2026-06
0
1.4
This device (reports/month)Average device in KTT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Osteocentric Technologies, Inc.
VAI 2023-11-13 OsteoCentric Technologies, Inc. · 3 citations
VAI 2023-11-13 OsteoCentric Technologies, Inc. · 3 citations
NAI 2016-08-30 OsteoCentric Technologies, Inc. · 0 citations
NAI 2016-08-30 OsteoCentric Technologies, Inc. · 0 citations