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Unnamed device
Model 3717005 · MEDTRONIC XOMED, INC. · DI 00681490087452
HBC — Motor, Drill, Electric · Class II · 21 CFR 882.4360
HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310
HRX — Arthroscope · Class II · 21 CFR 888.1100
HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment · Class I · 21 CFR 878.4820
UDILibrary device dossier · generated 2026-09-13 · 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
5.61
2019-02
0
3.34
2019-03
0
4.48
2019-04
0
3.9
2019-05
0
4.16
2019-06
0
3.98
2019-07
0
3.31
2019-08
0
4.03
2019-09
0
4.02
2019-10
0
3.74
2019-11
0
4.11
2019-12
0
4.74
2020-01
0
3.99
2020-02
0
4.67
2020-03
0
5.28
2020-04
0
3.62
2020-05
0
3.27
2020-06
0
4.85
2020-07
0
4.29
2020-08
0
4.16
2020-09
0
5.6
2020-10
0
4.97
2020-11
0
4.78
2020-12
0
5.96
2021-01
0
4.11
2021-02
0
4.59
2021-03
0
5.42
2021-04
0
4.13
2021-05
0
4.43
2021-06
0
4.54
2021-07
0
3.7
2021-08
0
4.35
2021-09
0
3.28
2021-10
0
3.25
2021-11
0
3.56
2021-12
0
4.09
2022-01
0
3.32
2022-02
0
3.47
2022-03
0
3.9
2022-04
0
3.1
2022-05
0
3.5
2022-06
0
4.18
2022-07
0
3.27
2022-08
0
3.95
2022-09
0
4.35
2022-10
0
3.62
2022-11
0
4.32
2022-12
0
4.7
2023-01
0
3.42
2023-02
0
3.98
2023-03
0
4.17
2023-04
0
3.53
2023-05
0
4.52
2023-06
0
4.18
2023-07
0
3.58
2023-08
0
3.98
2023-09
0
4.01
2023-10
0
3.01
2023-11
0
5.39
2023-12
0
5.36
2024-01
0
3.87
2024-02
0
4.8
2024-03
0
4.09
2024-04
0
3.74
2024-05
0
5.21
2024-06
0
5.77
2024-07
0
3.21
2024-08
0
3.36
2024-09
0
4.27
2024-10
0
3.6
2024-11
0
3.57
2024-12
0
4.75
2025-01
0
4.04
2025-02
0
4.87
2025-03
0
4.36
2025-04
0
2.7
2025-05
0
4.03
2025-06
0
3.81
2025-07
0
3.43
2025-08
0
3.22
2025-09
0
3.22
2025-10
0
3.32
2025-11
0
4.19
2025-12
0
4.21
2026-01
0
3.06
2026-02
0
3.65
2026-03
0
4.19
2026-04
0
4.73
2026-05
0
4.32
2026-06
0
8.81
This device (reports/month)Average device in HBC, HBE, HRX, HWE (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K081475 — cited as predicate by K111520, K121264, K130755, K132264, K133061, K141122, K143399, K160713, K163565, K170312, K193630, K233958, K240568
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC XOMED, INC.
VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations