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Accu-Joint
Model AJMI-M9-SUS · Accufix Surgical, Inc. · DI 00850061635198
KWD — Prosthesis, Toe, Hemi-, Phalangeal · Class II · 21 CFR 888.3730
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)
2019-06
0
3
2019-07
0
1
2022-05
0
1
2023-02
0
2.5
2023-04
0
3
2023-06
0
3
2023-07
0
3
2023-10
0
2
2024-02
0
4
2024-05
0
3
2024-12
0
2
2026-04
0
1
2026-06
0
1
This device (reports/month)Average device in KWD (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Accufix Surgical, Inc.
NAI 2025-04-30 Accufix Surgical, Inc. · 0 citations
NAI 2025-04-30 Accufix Surgical, Inc. · 0 citations