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5.5 X 24mm Citrefix Implant
Model 30-110-7055 · Acuitive Technologies, Inc. · DI 00810027270429
MAI — Fastener, Fixation, Biodegradable, Soft Tissue · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
UDILibrary device dossier · generated 2026-09-14 · 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
4.81
2019-02
0
2.35
2019-03
0
2.87
2019-04
0
2.83
2019-05
0
2.88
2019-06
0
2.7
2019-07
0
3.17
2019-08
0
3.13
2019-09
0
3.25
2019-10
0
3.1
2019-11
0
4.14
2019-12
0
4.54
2020-01
0
4.47
2020-02
0
3.61
2020-03
0
3.47
2020-04
0
4.66
2020-05
0
3.33
2020-06
0
3.45
2020-07
0
3.38
2020-08
0
3.88
2020-09
0
3.51
2020-10
0
4.09
2020-11
0
5.72
2020-12
0
4.91
2021-01
0
4.29
2021-02
0
3.59
2021-03
0
3.66
2021-04
0
4.01
2021-05
0
3.87
2021-06
0
3.56
2021-07
0
3.49
2021-08
0
3.93
2021-09
0
3.88
2021-10
0
4.07
2021-11
0
4.04
2021-12
0
4.01
2022-01
0
4.12
2022-02
0
3.29
2022-03
0
3.68
2022-04
0
3.67
2022-05
0
3.57
2022-06
0
3.4
2022-07
0
3.5
2022-08
0
3.94
2022-09
0
3.59
2022-10
0
3.85
2022-11
0
2.75
2022-12
0
3.79
2023-01
0
3.26
2023-02
0
3.11
2023-03
0
3.64
2023-04
0
4.08
2023-05
0
4.24
2023-06
0
4.04
2023-07
0
3.55
2023-08
0
3.96
2023-09
0
4.1
2023-10
0
3.98
2023-11
0
4.16
2023-12
0
4.91
2024-01
0
4.96
2024-02
0
4.17
2024-03
0
4.26
2024-04
0
4.61
2024-05
0
5.15
2024-06
0
5.83
2024-07
0
3.8
2024-08
0
3.63
2024-09
0
4.51
2024-10
0
4.17
2024-11
0
4.09
2024-12
0
4.16
2025-01
0
4.72
2025-02
0
4.19
2025-03
0
4.25
2025-04
0
4.4
2025-05
0
4.96
2025-06
0
4.89
2025-07
0
4.76
2025-08
0
4.71
2025-09
0
4.12
2025-10
0
4.33
2025-11
0
4.83
2025-12
0
5.8
2026-01
0
4.94
2026-02
0
5.12
2026-03
0
5.49
2026-04
0
5.44
2026-05
0
5.91
2026-06
0
5.86
This device (reports/month)Average device in MAI, MBI (reports/device/month)
Regulatory clearances
K203334 SESE 2021-02-05 (k number procode)
Predicate lineage
K203334 — cites (transitively): K051219 (d1), K200725 (d1), K051726 (d2) — cited as predicate by K220833, K232592
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Acuitive Technologies, Inc.