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Unnamed device

Model 402.208 · Synthes GmbH · DI 10886982205704

HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030

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

KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-16 · 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 (1)

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.

Malfunction: 1

12342019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1.57/device2019-03: 0 reports for this device; peer average 1.71/device2019-04: 0 reports for this device; peer average 2.26/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.72/device2019-07: 0 reports for this device; peer average 1.93/device2019-08: 0 reports for this device; peer average 1.83/device2019-09: 0 reports for this device; peer average 1.69/device2019-10: 0 reports for this device; peer average 1.58/device2019-11: 0 reports for this device; peer average 1.82/device2019-12: 0 reports for this device; peer average 2.19/device2020-01: 0 reports for this device; peer average 2.33/device2020-02: 0 reports for this device; peer average 1.48/device2020-03: 0 reports for this device; peer average 1.74/device2020-04: 0 reports for this device; peer average 1.84/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.27/device2020-08: 0 reports for this device; peer average 2.39/device2020-09: 0 reports for this device; peer average 2.56/device2020-10: 0 reports for this device; peer average 2.12/device2020-11: 0 reports for this device; peer average 2.53/device2020-12: 0 reports for this device; peer average 2.37/device2021-01: 0 reports for this device; peer average 1.8/device2021-02: 0 reports for this device; peer average 2.19/device2021-03: 0 reports for this device; peer average 2.41/device2021-04: 0 reports for this device; peer average 2.72/device2021-05: 0 reports for this device; peer average 2.55/device2021-06: 0 reports for this device; peer average 2.11/device2021-07: 0 reports for this device; peer average 2.22/device2021-08: 0 reports for this device; peer average 1.94/device2021-09: 0 reports for this device; peer average 2.18/device2021-10: 0 reports for this device; peer average 1.98/device2021-11: 0 reports for this device; peer average 2.26/device2021-12: 0 reports for this device; peer average 2.23/device2022-01: 0 reports for this device; peer average 2.83/device2022-02: 0 reports for this device; peer average 2.22/device2022-03: 0 reports for this device; peer average 1.91/device2022-04: 0 reports for this device; peer average 2.01/device2022-05: 0 reports for this device; peer average 2.31/device2022-06: 0 reports for this device; peer average 2.27/device2022-07: 0 reports for this device; peer average 2.2/device2022-08: 0 reports for this device; peer average 2.28/device2022-09: 0 reports for this device; peer average 2.68/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 3.02/device2022-12: 0 reports for this device; peer average 4.35/device2023-01: 0 reports for this device; peer average 2.66/device2023-02: 0 reports for this device; peer average 2.69/device2023-03: 0 reports for this device; peer average 2.95/device2023-04: 0 reports for this device; peer average 2.85/device2023-05: 0 reports for this device; peer average 3.55/device2023-06: 0 reports for this device; peer average 2.89/device2023-07: 0 reports for this device; peer average 2.25/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 2.06/device2023-10: 0 reports for this device; peer average 2.2/device2023-11: 0 reports for this device; peer average 1.89/device2023-12: 0 reports for this device; peer average 2.37/device2024-01: 0 reports for this device; peer average 2.45/device2024-02: 0 reports for this device; peer average 1.8/device2024-03: 0 reports for this device; peer average 2.08/device2024-04: 0 reports for this device; peer average 2.1/device2024-05: 0 reports for this device; peer average 2.11/device2024-06: 0 reports for this device; peer average 2.25/device2024-07: 0 reports for this device; peer average 2.31/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 1.91/device2024-10: 0 reports for this device; peer average 2.22/device2024-11: 0 reports for this device; peer average 1.89/device2024-12: 0 reports for this device; peer average 2.84/device2025-01: 0 reports for this device; peer average 1.97/device2025-02: 0 reports for this device; peer average 2.02/device2025-03: 0 reports for this device; peer average 2.28/device2025-04: 0 reports for this device; peer average 2.28/device2025-05: 0 reports for this device; peer average 2.31/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 2.1/device2025-08: 0 reports for this device; peer average 2.19/device2025-09: 0 reports for this device; peer average 1.94/device2025-10: 0 reports for this device; peer average 2.32/device2025-11: 0 reports for this device; peer average 1.98/device2025-12: 0 reports for this device; peer average 2.56/device2026-01: 0 reports for this device; peer average 1.9/device2026-02: 1 reports for this device; peer average 2.16/device2026-03: 0 reports for this device; peer average 2.69/device2026-04: 0 reports for this device; peer average 2.17/device2026-05: 0 reports for this device; peer average 2.45/device2026-06: 0 reports for this device; peer average 2.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.57
2019-0301.71
2019-0402.26
2019-0501.69
2019-0601.72
2019-0701.93
2019-0801.83
2019-0901.69
2019-1001.58
2019-1101.82
2019-1202.19
2020-0102.33
2020-0201.48
2020-0301.74
2020-0401.84
2020-0501.71
2020-0602
2020-0702.27
2020-0802.39
2020-0902.56
2020-1002.12
2020-1102.53
2020-1202.37
2021-0101.8
2021-0202.19
2021-0302.41
2021-0402.72
2021-0502.55
2021-0602.11
2021-0702.22
2021-0801.94
2021-0902.18
2021-1001.98
2021-1102.26
2021-1202.23
2022-0102.83
2022-0202.22
2022-0301.91
2022-0402.01
2022-0502.31
2022-0602.27
2022-0702.2
2022-0802.28
2022-0902.68
2022-1003
2022-1103.02
2022-1204.35
2023-0102.66
2023-0202.69
2023-0302.95
2023-0402.85
2023-0503.55
2023-0602.89
2023-0702.25
2023-0802.11
2023-0902.06
2023-1002.2
2023-1101.89
2023-1202.37
2024-0102.45
2024-0201.8
2024-0302.08
2024-0402.1
2024-0502.11
2024-0602.25
2024-0702.31
2024-0802.14
2024-0901.91
2024-1002.22
2024-1101.89
2024-1202.84
2025-0101.97
2025-0202.02
2025-0302.28
2025-0402.28
2025-0502.31
2025-0601.84
2025-0702.1
2025-0802.19
2025-0901.94
2025-1002.32
2025-1101.98
2025-1202.56
2026-0101.9
2026-0212.16
2026-0302.69
2026-0402.17
2026-0502.45
2026-0602.13
This device (reports/month)Average device in HRS, HWC, KTT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K033995 — cited as predicate by K112560, K113733, K120717, K132787, K141677, K141680, K150561, K153374, K153716, K161696, K163383, K180310, K191793, K192619, K200367, K213108, K222282, K232394, K233873

K050110 — cited as predicate by K111253, K153374, K190391, K190750, K190992, K200575

K113364 — cites (transitively): K001941 (d1), K063049 (d1), K073228 (d1) — cited as predicate by K160553

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