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2.9 X 12.5mm Citrefix XPress System
Model 70-810-2912 · Acuitive Technologies, Inc. · DI 00810027270856
HTW — Bit, Drill · Class I · 21 CFR 888.4540
HXG — Tamp · Class I · 21 CFR 888.4540
HXY — Brace, Drill · Class I · 21 CFR 888.4540
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 2026-09-12 · 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
4.53
2019-02
0
2.79
2019-03
0
2.78
2019-04
0
2.7
2019-05
0
2.78
2019-06
0
2.7
2019-07
0
2.83
2019-08
0
3.02
2019-09
0
3.18
2019-10
0
3.28
2019-11
0
4.21
2019-12
0
4.42
2020-01
0
4.47
2020-02
0
3.73
2020-03
0
3.61
2020-04
0
4.19
2020-05
0
3.24
2020-06
0
3.64
2020-07
0
3.88
2020-08
0
4.41
2020-09
0
3.77
2020-10
0
4.17
2020-11
0
5.5
2020-12
0
4.92
2021-01
0
4.49
2021-02
0
3.58
2021-03
0
3.77
2021-04
0
3.96
2021-05
0
4.06
2021-06
0
3.94
2021-07
0
3.6
2021-08
0
4.01
2021-09
0
4.18
2021-10
0
4.03
2021-11
0
4.13
2021-12
0
4.04
2022-01
0
4.22
2022-02
0
3.7
2022-03
0
3.85
2022-04
0
4.03
2022-05
0
3.57
2022-06
0
3.72
2022-07
0
3.33
2022-08
0
4.15
2022-09
0
3.69
2022-10
0
3.93
2022-11
0
3.06
2022-12
0
4.3
2023-01
0
3.56
2023-02
0
3.46
2023-03
0
4.35
2023-04
0
4.62
2023-05
0
4.49
2023-06
0
4.25
2023-07
0
3.72
2023-08
0
3.84
2023-09
0
3.82
2023-10
0
3.9
2023-11
0
3.9
2023-12
0
4.42
2024-01
0
4.43
2024-02
0
4
2024-03
0
3.86
2024-04
0
4.55
2024-05
0
4.78
2024-06
0
5.27
2024-07
0
3.54
2024-08
0
3.52
2024-09
0
4.12
2024-10
0
3.99
2024-11
0
4.02
2024-12
0
3.89
2025-01
0
4.61
2025-02
0
3.83
2025-03
0
3.99
2025-04
0
4.15
2025-05
0
4.88
2025-06
0
4.58
2025-07
0
4.42
2025-08
0
4.55
2025-09
0
3.94
2025-10
0
4.13
2025-11
0
4.65
2025-12
0
5.43
2026-01
0
4.6
2026-02
0
4.59
2026-03
0
5.17
2026-04
0
5.18
2026-05
0
5.45
2026-06
0
5.39
This device (reports/month)Average device in HTW, HXG, HXY, 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.