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MIDAS REX CURVED BUR
Model CB11BA30 · MEDTRONIC POWERED SURGICAL SOLUTIONS · DI 00763000517632
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
UDILibrary device dossier · generated 2026-09-06 · 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
2.29
2019-02
0
3.68
2019-03
0
4.9
2019-04
0
3.39
2019-05
0
4
2019-06
0
3.65
2019-07
0
3.23
2019-08
0
3.89
2019-09
0
2.94
2019-10
0
3
2019-11
0
3.32
2019-12
0
3.76
2020-01
0
3.19
2020-02
0
6.36
2020-03
0
5.11
2020-04
0
3.12
2020-05
0
2.9
2020-06
0
4.24
2020-07
0
3.8
2020-08
0
3.06
2020-09
0
4.6
2020-10
0
3.78
2020-11
0
4.29
2020-12
0
4.34
2021-01
0
3.3
2021-02
0
3.03
2021-03
0
3.51
2021-04
0
2.92
2021-05
0
2.73
2021-06
0
3.62
2021-07
0
3.29
2021-08
0
4.9
2021-09
0
3.59
2021-10
0
2.88
2021-11
0
3.54
2021-12
0
4.3
2022-01
0
2.93
2022-02
0
3.79
2022-03
0
3.94
2022-04
0
2.55
2022-05
0
3.36
2022-06
0
3.9
2022-07
0
3.02
2022-08
0
3.9
2022-09
0
4.04
2022-10
0
3.41
2022-11
0
3.62
2022-12
0
4.61
2023-01
0
3.21
2023-02
0
3.83
2023-03
0
3.93
2023-04
0
3.25
2023-05
0
4.68
2023-06
0
4.04
2023-07
0
2.9
2023-08
0
3.5
2023-09
0
3.58
2023-10
0
2.62
2023-11
0
4.11
2023-12
0
2.85
2024-01
0
3.18
2024-02
0
3.13
2024-03
0
3.59
2024-04
0
2.68
2024-05
0
2.7
2024-06
0
3.29
2024-07
0
2.6
2024-08
0
2.75
2024-09
0
3.49
2024-10
0
2.67
2024-11
0
2.16
2024-12
0
3.35
2025-01
0
2.56
2025-02
0
3.52
2025-03
0
2.34
2025-04
0
1.85
2025-05
0
2.19
2025-06
0
2.48
2025-07
0
2.47
2025-08
0
1.85
2025-09
0
2
2025-10
0
2.75
2025-11
0
3.08
2025-12
0
2.91
2026-01
0
2.01
2026-02
0
2.5
2026-03
0
4.3
2026-04
0
4.4
2026-05
0
4.84
2026-06
0
15.24
This device (reports/month)Average device in HBE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K072315 — cited as predicate by K163182, K170312
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC POWERED SURGICAL SOLUTIONS
NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations