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Mergence™-S

Model 96-101-03041 · ZIMMER TRABECULAR METAL TECHNOLOGY INC. · DI 00889024316331

HXB — Probe · Class I · 21 CFR 888.4540

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

UDILibrary device dossier · generated 2026-09-11 · 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
2019-02	0	2.5
2019-03	0	1.4
2019-04	0	2.4
2019-05	0	2
2019-06	0	1.5
2019-07	0	1.71
2019-08	0	5.22
2019-09	0	1.4
2019-10	0	3.17
2019-11	0	1.6
2019-12	0	2
2020-01	0	2.14
2020-02	0	1.5
2020-03	0	1.5
2020-04	0	1.71
2020-05	0	1.57
2020-06	0	1.33
2020-07	0	1.33
2020-08	0	1.45
2020-09	0	1.63
2020-10	0	1.69
2020-11	0	2.43
2020-12	0	2.14
2021-01	0	1.6
2021-02	0	1.8
2021-03	0	1.88
2021-04	0	1.25
2021-05	0	1.25
2021-06	0	3.88
2021-07	0	2.25
2021-08	0	1.8
2021-09	0	2
2021-10	0	1
2021-11	0	1.5
2021-12	0	1.56
2022-01	0	1.33
2022-02	0	1.44
2022-03	0	1.64
2022-04	0	1.57
2022-05	0	1.73
2022-06	0	2
2022-07	0	1.5
2022-08	0	1.56
2022-09	0	2.42
2022-10	0	1.42
2022-11	0	1.56
2022-12	0	1.8
2023-01	0	1.78
2023-02	0	2
2023-03	0	1.9
2023-04	0	1.5
2023-05	0	1.88
2023-06	0	1.86
2023-07	0	1.75
2023-08	0	5
2023-09	0	1
2023-10	0	1.43
2023-11	0	1.6
2023-12	0	1.5
2024-01	0	3
2024-02	0	1.67
2024-03	0	1.33
2024-04	0	1.29
2024-05	0	1.4
2024-06	0	1.4
2024-07	0	2.17
2024-08	0	1.75
2024-09	0	1.71
2024-10	0	1.17
2024-11	0	1.5
2024-12	0	1.71
2025-01	0	1.43
2025-02	0	1.91
2025-03	0	1.46
2025-04	0	1.89
2025-05	0	1.4
2025-06	0	2
2025-07	0	2.29
2025-08	0	1.63
2025-09	0	1.4
2025-10	0	1.5
2025-11	0	2.33
2025-12	0	2.22
2026-01	0	1.33
2026-02	0	1.36
2026-03	0	1.75
2026-04	0	1.5
2026-05	0	1.71
2026-06	0	1.85

This device (reports/month)Average device in HXB, ODP (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Predicate lineage

K111119 — cites (transitively): K081917 (d1), K103033 (d1), K070754 (d2), P000028 (d2), P980048 (d2) — cited as predicate by K132894, K173159, K181621, K241073, K242260

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

Manufacturer compliance record — ZIMMER TRABECULAR METAL TECHNOLOGY INC.

NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
VAI 2013-06-06 Zimmer Trabecular Metal Technology, Inc. · 1 citations
NAI 2012-05-21 Zimmer Trabecular Metal Technology, Inc. · 0 citations