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Unnamed device

Model 04.617.812 · Synthes GmbH · DI 10705034742250

KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060

OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical · 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.

12342019-01: 0 reports for this device; peer average 2.02/device2019-02: 0 reports for this device; peer average 1.83/device2019-03: 0 reports for this device; peer average 1.85/device2019-04: 0 reports for this device; peer average 1.83/device2019-05: 0 reports for this device; peer average 1.9/device2019-06: 0 reports for this device; peer average 1.98/device2019-07: 0 reports for this device; peer average 1.74/device2019-08: 0 reports for this device; peer average 2.82/device2019-09: 0 reports for this device; peer average 1.73/device2019-10: 0 reports for this device; peer average 2.06/device2019-11: 0 reports for this device; peer average 2.09/device2019-12: 0 reports for this device; peer average 1.72/device2020-01: 0 reports for this device; peer average 3.2/device2020-02: 0 reports for this device; peer average 1.98/device2020-03: 0 reports for this device; peer average 1.92/device2020-04: 0 reports for this device; peer average 1.63/device2020-05: 0 reports for this device; peer average 2.08/device2020-06: 0 reports for this device; peer average 2.11/device2020-07: 0 reports for this device; peer average 2.05/device2020-08: 0 reports for this device; peer average 1.79/device2020-09: 0 reports for this device; peer average 2.25/device2020-10: 0 reports for this device; peer average 2.38/device2020-11: 0 reports for this device; peer average 2.63/device2020-12: 0 reports for this device; peer average 2.03/device2021-01: 0 reports for this device; peer average 1.73/device2021-02: 0 reports for this device; peer average 2.04/device2021-03: 0 reports for this device; peer average 2.24/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 2.21/device2021-06: 0 reports for this device; peer average 1.98/device2021-07: 0 reports for this device; peer average 2.2/device2021-08: 0 reports for this device; peer average 2.22/device2021-09: 0 reports for this device; peer average 1.86/device2021-10: 0 reports for this device; peer average 2.63/device2021-11: 0 reports for this device; peer average 2.05/device2021-12: 0 reports for this device; peer average 2.48/device2022-01: 0 reports for this device; peer average 2.28/device2022-02: 0 reports for this device; peer average 2.12/device2022-03: 0 reports for this device; peer average 1.74/device2022-04: 0 reports for this device; peer average 1.65/device2022-05: 0 reports for this device; peer average 1.88/device2022-06: 0 reports for this device; peer average 2.11/device2022-07: 0 reports for this device; peer average 3.19/device2022-08: 0 reports for this device; peer average 2.14/device2022-09: 0 reports for this device; peer average 2.76/device2022-10: 0 reports for this device; peer average 1.61/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.17/device2023-02: 0 reports for this device; peer average 2.13/device2023-03: 0 reports for this device; peer average 2.31/device2023-04: 0 reports for this device; peer average 1.8/device2023-05: 0 reports for this device; peer average 1.88/device2023-06: 0 reports for this device; peer average 1.6/device2023-07: 0 reports for this device; peer average 1.92/device2023-08: 0 reports for this device; peer average 1.36/device2023-09: 0 reports for this device; peer average 2.61/device2023-10: 0 reports for this device; peer average 2.35/device2023-11: 0 reports for this device; peer average 2.27/device2023-12: 0 reports for this device; peer average 1.76/device2024-01: 0 reports for this device; peer average 2.32/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 3.47/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 2.79/device2024-06: 0 reports for this device; peer average 3.52/device2024-07: 0 reports for this device; peer average 2.1/device2024-08: 0 reports for this device; peer average 1.71/device2024-09: 0 reports for this device; peer average 2.82/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.64/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 2.19/device2025-02: 0 reports for this device; peer average 2.51/device2025-03: 0 reports for this device; peer average 2.36/device2025-04: 0 reports for this device; peer average 2.14/device2025-05: 0 reports for this device; peer average 2.66/device2025-06: 0 reports for this device; peer average 2.35/device2025-07: 0 reports for this device; peer average 2.04/device2025-08: 0 reports for this device; peer average 1.95/device2025-09: 0 reports for this device; peer average 2.02/device2025-10: 0 reports for this device; peer average 1.88/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2.55/device2026-01: 0 reports for this device; peer average 2.57/device2026-02: 0 reports for this device; peer average 2.39/device2026-03: 0 reports for this device; peer average 2.66/device2026-04: 0 reports for this device; peer average 1.86/device2026-05: 0 reports for this device; peer average 2.64/device2026-06: 0 reports for this device; peer average 4.23/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.02
2019-0201.83
2019-0301.85
2019-0401.83
2019-0501.9
2019-0601.98
2019-0701.74
2019-0802.82
2019-0901.73
2019-1002.06
2019-1102.09
2019-1201.72
2020-0103.2
2020-0201.98
2020-0301.92
2020-0401.63
2020-0502.08
2020-0602.11
2020-0702.05
2020-0801.79
2020-0902.25
2020-1002.38
2020-1102.63
2020-1202.03
2021-0101.73
2021-0202.04
2021-0302.24
2021-0401.88
2021-0502.21
2021-0601.98
2021-0702.2
2021-0802.22
2021-0901.86
2021-1002.63
2021-1102.05
2021-1202.48
2022-0102.28
2022-0202.12
2022-0301.74
2022-0401.65
2022-0501.88
2022-0602.11
2022-0703.19
2022-0802.14
2022-0902.76
2022-1001.61
2022-1102
2022-1202.13
2023-0102.17
2023-0202.13
2023-0302.31
2023-0401.8
2023-0501.88
2023-0601.6
2023-0701.92
2023-0801.36
2023-0902.61
2023-1002.35
2023-1102.27
2023-1201.76
2024-0102.32
2024-0202.08
2024-0303.47
2024-0401.66
2024-0502.79
2024-0603.52
2024-0702.1
2024-0801.71
2024-0902.82
2024-1002.13
2024-1101.64
2024-1201.63
2025-0102.19
2025-0202.51
2025-0302.36
2025-0402.14
2025-0502.66
2025-0602.35
2025-0702.04
2025-0801.95
2025-0902.02
2025-1001.88
2025-1102
2025-1202.55
2026-0102.57
2026-0202.39
2026-0302.66
2026-0401.86
2026-0502.64
2026-0604.23
This device (reports/month)Average device in KWQ, OVE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K072981 — cited as predicate by K113796, K150673, K152532, K153250, K172424, K253213

K152239 — cites (transitively): K071667 (d1), K141500 (d1), K012305 (d2), K030866 (d2), K031276 (d2), K132894 (d2), K971883 (d2), K073351 (d3), K103033 (d3), K111119 (d3), K112388 (d3), K120345 (d3), K070754 (d4), P000028 (d4), P980048 (d4), K081917 (d4), K083389 (d4), K094042 (d4), K042571 (d4), K050624 (d4), K061836 (d4), K062132 (d4), K082014 (d4), P960025 (d4)

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

Manufacturer compliance record — Synthes GmbH

  • Warning Letter 2012-02-16 Synthes, Inc.
  • NAI 2017-08-08 Synthes GmbH · 0 citations
  • NAI 2017-01-18 Synthes (USA), LLC · 0 citations
  • VAI 2015-05-08 Synthes (USA), LLC · 2 citations
  • VAI 2013-11-13 Synthes, Inc. · 1 citations
  • NAI 2013-05-16 Synthes, Inc. · 0 citations
  • VAI 2012-10-19 Synthes, Inc. · 1 citations
  • NAI 2012-02-01 Synthes (USA), LLC · 0 citations
  • OAI 2011-09-15 Synthes, Inc. · 10 citations