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SynMesh
Model 495.648 · Synthes GmbH · DI 10705034786469
MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060
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
2019-02
0
1.38
2019-03
0
2.14
2019-04
0
1
2019-05
0
1.57
2019-06
0
2.14
2019-07
0
1.36
2019-08
0
2
2019-09
0
1
2019-10
0
1.4
2019-11
0
1
2019-12
0
1.64
2020-01
0
1.57
2020-02
0
1.2
2020-03
0
1.43
2020-04
0
1.25
2020-05
0
1.2
2020-06
0
1.33
2020-07
0
2.5
2020-08
0
1.45
2020-09
0
1.62
2020-10
0
1.67
2020-11
0
1.13
2020-12
0
1.5
2021-01
0
1.31
2021-02
0
1.33
2021-03
0
1.78
2021-04
0
1.47
2021-05
0
1.29
2021-06
0
2.69
2021-07
0
1.58
2021-08
0
1.64
2021-09
0
1.38
2021-10
0
1.67
2021-11
0
1.44
2021-12
0
1.45
2022-01
0
1.38
2022-02
0
1.59
2022-03
0
1.67
2022-04
0
1.64
2022-05
0
1.79
2022-06
0
1.64
2022-07
0
1.44
2022-08
0
1.4
2022-09
0
2.29
2022-10
0
1.5
2022-11
0
1.8
2022-12
0
1.33
2023-01
0
2
2023-02
0
1.44
2023-03
0
3
2023-04
0
1.17
2023-05
0
1.31
2023-06
0
1.25
2023-07
0
2
2023-08
0
1.63
2023-09
0
1.63
2023-10
0
1.67
2023-11
0
1.22
2023-12
0
1.37
2024-01
0
1.8
2024-02
0
1.75
2024-03
0
2
2024-04
0
1.56
2024-05
0
2.25
2024-06
0
1.5
2024-07
0
1.62
2024-08
0
1.07
2024-09
0
1.55
2024-10
0
1.29
2024-11
0
1.38
2024-12
0
1.47
2025-01
0
1.38
2025-02
0
1.75
2025-03
0
3.63
2025-04
0
1.67
2025-05
0
2.2
2025-06
0
1.54
2025-07
0
1.45
2025-08
0
1.71
2025-09
0
1.56
2025-10
0
1.56
2025-11
0
1.53
2025-12
0
1.57
2026-01
0
1.4
2026-02
0
1.18
2026-03
0
1.9
2026-04
0
1.8
2026-05
0
1.67
2026-06
0
1.75
This device (reports/month)Average device in MQP (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K041389 — cited as predicate by K103320, K112756, K183197, K190147
Lineage extracted from public 510(k) summary text (heuristic).