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Unnamed device

Model 400.534 · Synthes GmbH · DI 10886982203496

DZL — Screw, Fixation, Intraosseous · Class II · 21 CFR 872.4880

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-12 · 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.

13462019-01: 0 reports for this device; peer average 2.09/device2019-02: 0 reports for this device; peer average 1.59/device2019-03: 0 reports for this device; peer average 1.64/device2019-04: 0 reports for this device; peer average 2.23/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.83/device2019-07: 0 reports for this device; peer average 2.05/device2019-08: 0 reports for this device; peer average 2.01/device2019-09: 0 reports for this device; peer average 1.76/device2019-10: 0 reports for this device; peer average 1.68/device2019-11: 0 reports for this device; peer average 1.98/device2019-12: 0 reports for this device; peer average 2.47/device2020-01: 0 reports for this device; peer average 2.49/device2020-02: 0 reports for this device; peer average 2.11/device2020-03: 0 reports for this device; peer average 1.89/device2020-04: 0 reports for this device; peer average 1.88/device2020-05: 0 reports for this device; peer average 1.75/device2020-06: 0 reports for this device; peer average 2.04/device2020-07: 0 reports for this device; peer average 2.65/device2020-08: 0 reports for this device; peer average 2.49/device2020-09: 0 reports for this device; peer average 2.43/device2020-10: 0 reports for this device; peer average 2.2/device2020-11: 0 reports for this device; peer average 2.81/device2020-12: 0 reports for this device; peer average 2.43/device2021-01: 0 reports for this device; peer average 1.87/device2021-02: 0 reports for this device; peer average 2.29/device2021-03: 0 reports for this device; peer average 2.57/device2021-04: 0 reports for this device; peer average 2.7/device2021-05: 0 reports for this device; peer average 2.37/device2021-06: 0 reports for this device; peer average 2.21/device2021-07: 0 reports for this device; peer average 2.27/device2021-08: 0 reports for this device; peer average 2.06/device2021-09: 0 reports for this device; peer average 2.35/device2021-10: 0 reports for this device; peer average 2.04/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 2.37/device2022-01: 0 reports for this device; peer average 2.94/device2022-02: 0 reports for this device; peer average 2.17/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 1.95/device2022-05: 0 reports for this device; peer average 2.71/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 2.18/device2022-08: 0 reports for this device; peer average 2.57/device2022-09: 0 reports for this device; peer average 2.86/device2022-10: 0 reports for this device; peer average 3.2/device2022-11: 0 reports for this device; peer average 2.99/device2022-12: 0 reports for this device; peer average 5.73/device2023-01: 0 reports for this device; peer average 2.71/device2023-02: 0 reports for this device; peer average 2.84/device2023-03: 0 reports for this device; peer average 3.47/device2023-04: 0 reports for this device; peer average 2.76/device2023-05: 0 reports for this device; peer average 3.27/device2023-06: 0 reports for this device; peer average 2.93/device2023-07: 0 reports for this device; peer average 2.27/device2023-08: 0 reports for this device; peer average 2.15/device2023-09: 0 reports for this device; peer average 2.04/device2023-10: 0 reports for this device; peer average 2.09/device2023-11: 0 reports for this device; peer average 1.86/device2023-12: 0 reports for this device; peer average 2.47/device2024-01: 0 reports for this device; peer average 2.81/device2024-02: 0 reports for this device; peer average 1.81/device2024-03: 0 reports for this device; peer average 2.32/device2024-04: 0 reports for this device; peer average 2.1/device2024-05: 0 reports for this device; peer average 2.29/device2024-06: 0 reports for this device; peer average 2.24/device2024-07: 0 reports for this device; peer average 2.46/device2024-08: 0 reports for this device; peer average 2.12/device2024-09: 0 reports for this device; peer average 2.18/device2024-10: 0 reports for this device; peer average 2.14/device2024-11: 0 reports for this device; peer average 2.01/device2024-12: 0 reports for this device; peer average 2.76/device2025-01: 0 reports for this device; peer average 2.21/device2025-02: 0 reports for this device; peer average 2.16/device2025-03: 0 reports for this device; peer average 2.06/device2025-04: 0 reports for this device; peer average 2.52/device2025-05: 0 reports for this device; peer average 2.47/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 2.12/device2025-08: 0 reports for this device; peer average 2.39/device2025-09: 0 reports for this device; peer average 2.07/device2025-10: 0 reports for this device; peer average 2.46/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 2.7/device2026-01: 0 reports for this device; peer average 2.05/device2026-02: 0 reports for this device; peer average 2.33/device2026-03: 0 reports for this device; peer average 2.59/device2026-04: 0 reports for this device; peer average 2.14/device2026-05: 0 reports for this device; peer average 2.53/device2026-06: 0 reports for this device; peer average 2.31/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.09
2019-0201.59
2019-0301.64
2019-0402.23
2019-0501.75
2019-0601.83
2019-0702.05
2019-0802.01
2019-0901.76
2019-1001.68
2019-1101.98
2019-1202.47
2020-0102.49
2020-0202.11
2020-0301.89
2020-0401.88
2020-0501.75
2020-0602.04
2020-0702.65
2020-0802.49
2020-0902.43
2020-1002.2
2020-1102.81
2020-1202.43
2021-0101.87
2021-0202.29
2021-0302.57
2021-0402.7
2021-0502.37
2021-0602.21
2021-0702.27
2021-0802.06
2021-0902.35
2021-1002.04
2021-1102.25
2021-1202.37
2022-0102.94
2022-0202.17
2022-0302.01
2022-0401.95
2022-0502.71
2022-0602.2
2022-0702.18
2022-0802.57
2022-0902.86
2022-1003.2
2022-1102.99
2022-1205.73
2023-0102.71
2023-0202.84
2023-0303.47
2023-0402.76
2023-0503.27
2023-0602.93
2023-0702.27
2023-0802.15
2023-0902.04
2023-1002.09
2023-1101.86
2023-1202.47
2024-0102.81
2024-0201.81
2024-0302.32
2024-0402.1
2024-0502.29
2024-0602.24
2024-0702.46
2024-0802.12
2024-0902.18
2024-1002.14
2024-1102.01
2024-1202.76
2025-0102.21
2025-0202.16
2025-0302.06
2025-0402.52
2025-0502.47
2025-0602.02
2025-0702.12
2025-0802.39
2025-0902.07
2025-1002.46
2025-1102.03
2025-1202.7
2026-0102.05
2026-0202.33
2026-0302.59
2026-0402.14
2026-0502.53
2026-0602.31
This device (reports/month)Average device in DZL, HWC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112583 — cites (transitively): K000682 (d1), K000684 (d1), K023879 (d1), K100776 (d1), K061808 (d2), K063049 (d2), K090063 (d2), K090675 (d2) — cited as predicate by K122489, K150099, K150561, K150981, K153374, K153638, K160553, K161616, K161894, K162124, K163383, K171320, K172383, K180541, K191793, K192745, K200062, K211051, K211435, K222282, K233665, K233873, K241815, K243469

K912932 — cited as predicate by K192655, K192702

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