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HONOUR™ Spacer System

Model 35-1618-110 · NEXXT SPINE, LLC · DI 00889929003770

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-07 · 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	1.59
2019-02	0	1.23
2019-03	0	1.71
2019-04	0	1.38
2019-05	0	1.59
2019-06	0	1.6
2019-07	0	1.63
2019-08	0	2.17
2019-09	0	1.29
2019-10	0	2.14
2019-11	0	1.5
2019-12	0	1.43
2020-01	0	1.62
2020-02	0	1.64
2020-03	0	1.46
2020-04	0	1.42
2020-05	0	1.51
2020-06	0	1.67
2020-07	0	1.92
2020-08	0	1.53
2020-09	0	2.23
2020-10	0	1.85
2020-11	0	1.72
2020-12	0	1.68
2021-01	0	1.53
2021-02	0	1.57
2021-03	0	1.9
2021-04	0	1.46
2021-05	0	1.44
2021-06	0	2.91
2021-07	0	1.63
2021-08	0	1.95
2021-09	0	1.69
2021-10	0	1.96
2021-11	0	1.71
2021-12	0	2
2022-01	0	2.37
2022-02	0	2.1
2022-03	0	1.73
2022-04	0	1.68
2022-05	0	2
2022-06	0	1.72
2022-07	0	1.88
2022-08	0	1.72
2022-09	0	1.93
2022-10	0	1.63
2022-11	0	1.92
2022-12	0	1.58
2023-01	0	2.39
2023-02	0	1.91
2023-03	0	1.9
2023-04	0	1.64
2023-05	0	1.75
2023-06	0	1.59
2023-07	0	1.97
2023-08	0	2.39
2023-09	0	1.79
2023-10	0	1.78
2023-11	0	7.72
2023-12	0	2.97
2024-01	0	1.89
2024-02	0	2.02
2024-03	0	1.89
2024-04	0	1.42
2024-05	0	1.65
2024-06	0	1.71
2024-07	0	1.83
2024-08	0	1.88
2024-09	0	1.82
2024-10	0	1.88
2024-11	0	1.67
2024-12	0	1.64
2025-01	0	1.71
2025-02	0	1.69
2025-03	0	1.96
2025-04	0	1.64
2025-05	0	1.81
2025-06	0	1.88
2025-07	0	1.79
2025-08	0	1.64
2025-09	0	1.57
2025-10	0	1.65
2025-11	0	1.86
2025-12	0	1.77
2026-01	0	1.72
2026-02	0	1.45
2026-03	0	2.38
2026-04	0	1.61
2026-05	0	1.61
2026-06	0	1.67

This device (reports/month)Average device in MAX, MQP, ODP (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K120345 — cites (transitively): K042571 (d1), K050624 (d1), K061836 (d1), K062132 (d1), K082014 (d1), P960025 (d1) — cited as predicate by K132894, K133529, K133827, K171140, K190546, K193412

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — NEXXT SPINE, LLC

VAI 2025-08-11 Nexxt Spine, LLC · 4 citations
VAI 2025-08-11 Nexxt Spine, LLC · 4 citations
VAI 2018-04-27 Nexxt Spine, LLC · 5 citations
VAI 2018-04-27 Nexxt Spine, LLC · 5 citations