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MD-Vue™ Lateral Discectomy System
Model 60-BK-5002 · PRECISION SPINE, INC. · DI 00840019936415
KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
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
1.95
2019-02
0
1.66
2019-03
0
1.78
2019-04
0
1.7
2019-05
0
1.83
2019-06
0
1.84
2019-07
0
1.71
2019-08
0
2.22
2019-09
0
1.58
2019-10
0
1.99
2019-11
0
1.99
2019-12
0
1.62
2020-01
0
2.4
2020-02
0
1.94
2020-03
0
1.81
2020-04
0
1.62
2020-05
0
2
2020-06
0
2.04
2020-07
0
1.98
2020-08
0
1.81
2020-09
0
2.33
2020-10
0
2.31
2020-11
0
2.52
2020-12
0
1.99
2021-01
0
1.74
2021-02
0
1.81
2021-03
0
2.21
2021-04
0
1.84
2021-05
0
1.79
2021-06
0
2.1
2021-07
0
2.09
2021-08
0
2.24
2021-09
0
1.81
2021-10
0
2.52
2021-11
0
2.02
2021-12
0
2.53
2022-01
0
2.62
2022-02
0
2.29
2022-03
0
1.8
2022-04
0
1.76
2022-05
0
2.03
2022-06
0
2.02
2022-07
0
3.02
2022-08
0
2.11
2022-09
0
2.52
2022-10
0
1.71
2022-11
0
2.03
2022-12
0
1.95
2023-01
0
2.2
2023-02
0
2.1
2023-03
0
2.04
2023-04
0
1.79
2023-05
0
2
2023-06
0
1.64
2023-07
0
1.98
2023-08
0
1.52
2023-09
0
2.34
2023-10
0
2.19
2023-11
0
5.79
2023-12
0
2.97
2024-01
0
2.21
2024-02
0
2.13
2024-03
0
3.12
2024-04
0
1.58
2024-05
0
2.66
2024-06
0
2.89
2024-07
0
2.08
2024-08
0
1.93
2024-09
0
2.53
2024-10
0
2.18
2024-11
0
1.71
2024-12
0
1.67
2025-01
0
2.08
2025-02
0
2.16
2025-03
0
2.02
2025-04
0
1.91
2025-05
0
2.33
2025-06
0
2.2
2025-07
0
1.93
2025-08
0
1.84
2025-09
0
1.82
2025-10
0
1.84
2025-11
0
2
2025-12
0
2.32
2026-01
0
2.38
2026-02
0
2.06
2026-03
0
2.8
2026-04
0
1.81
2026-05
0
2.01
2026-06
0
3.28
This device (reports/month)Average device in KWQ, MAX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K092193 — cited as predicate by K131082, K151819, K170503, K171657, K192026, K201287, K212075, K212980, K221182
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — PRECISION SPINE, INC.