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DynaNail Helix, Washer, 15 mm

Model 3300-00-1515 · Medshape, Inc. · DI M97033000015150

HTN — Washer, Bolt Nut · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-07 · 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.

23562019-01: 0 reports for this device; peer average 1.6/device2019-02: 0 reports for this device; peer average 1.4/device2019-03: 0 reports for this device; peer average 2.25/device2019-04: 0 reports for this device; peer average 2.5/device2019-05: 0 reports for this device; peer average 2.33/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.83/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 2.5/device2020-02: 0 reports for this device; peer average 3.18/device2020-03: 0 reports for this device; peer average 1.4/device2020-04: 0 reports for this device; peer average 2.6/device2020-05: 0 reports for this device; peer average 3.13/device2020-06: 0 reports for this device; peer average 3.25/device2020-07: 0 reports for this device; peer average 2.33/device2020-08: 0 reports for this device; peer average 3/device2020-09: 0 reports for this device; peer average 4.64/device2020-10: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 2.22/device2021-02: 0 reports for this device; peer average 2.91/device2021-03: 0 reports for this device; peer average 2.22/device2021-04: 0 reports for this device; peer average 2.56/device2021-05: 0 reports for this device; peer average 2.14/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1.8/device2021-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 2.45/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.92/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 3.2/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 2.6/device2022-04: 0 reports for this device; peer average 3.42/device2022-05: 0 reports for this device; peer average 2.14/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 4.9/device2022-09: 0 reports for this device; peer average 2.2/device2022-10: 0 reports for this device; peer average 1.57/device2022-11: 0 reports for this device; peer average 3.25/device2022-12: 0 reports for this device; peer average 3.67/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 2.88/device2023-04: 0 reports for this device; peer average 3.25/device2023-05: 0 reports for this device; peer average 3.67/device2023-06: 0 reports for this device; peer average 2.57/device2023-07: 0 reports for this device; peer average 1.8/device2023-08: 0 reports for this device; peer average 3.29/device2023-09: 0 reports for this device; peer average 1.67/device2023-10: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 3.33/device2023-12: 0 reports for this device; peer average 4.38/device2024-01: 0 reports for this device; peer average 3.92/device2024-02: 0 reports for this device; peer average 3.35/device2024-03: 0 reports for this device; peer average 2.92/device2024-04: 0 reports for this device; peer average 3.44/device2024-05: 0 reports for this device; peer average 4.87/device2024-06: 0 reports for this device; peer average 6.31/device2024-07: 0 reports for this device; peer average 3.73/device2024-08: 0 reports for this device; peer average 1.93/device2024-09: 0 reports for this device; peer average 2.85/device2024-10: 0 reports for this device; peer average 2.63/device2024-11: 0 reports for this device; peer average 2.5/device2024-12: 0 reports for this device; peer average 1.86/device2025-01: 0 reports for this device; peer average 3.5/device2025-02: 0 reports for this device; peer average 3.87/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 2.82/device2025-05: 0 reports for this device; peer average 5.6/device2025-06: 0 reports for this device; peer average 1.53/device2025-07: 0 reports for this device; peer average 3.42/device2025-08: 0 reports for this device; peer average 2.58/device2025-09: 0 reports for this device; peer average 2.27/device2025-10: 0 reports for this device; peer average 3.08/device2025-11: 0 reports for this device; peer average 2.42/device2025-12: 0 reports for this device; peer average 2.13/device2026-01: 0 reports for this device; peer average 2.7/device2026-02: 0 reports for this device; peer average 1.89/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 2.91/device2026-05: 0 reports for this device; peer average 3.25/device2026-06: 0 reports for this device; peer average 2.82/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.6
2019-0201.4
2019-0302.25
2019-0402.5
2019-0502.33
2019-0602
2019-0701
2019-0801.33
2019-0901.83
2019-1002
2019-1103
2019-1203
2020-0102.5
2020-0203.18
2020-0301.4
2020-0402.6
2020-0503.13
2020-0603.25
2020-0702.33
2020-0803
2020-0904.64
2020-1003
2020-1102.33
2020-1202
2021-0102.22
2021-0202.91
2021-0302.22
2021-0402.56
2021-0502.14
2021-0602
2021-0701.8
2021-0803
2021-0902.45
2021-1002
2021-1102.92
2021-1202
2022-0103.2
2022-0202.67
2022-0302.6
2022-0403.42
2022-0502.14
2022-0601.67
2022-0702
2022-0804.9
2022-0902.2
2022-1001.57
2022-1103.25
2022-1203.67
2023-0102.5
2023-0203
2023-0302.88
2023-0403.25
2023-0503.67
2023-0602.57
2023-0701.8
2023-0803.29
2023-0901.67
2023-1002.5
2023-1103.33
2023-1204.38
2024-0103.92
2024-0203.35
2024-0302.92
2024-0403.44
2024-0504.87
2024-0606.31
2024-0703.73
2024-0801.93
2024-0902.85
2024-1002.63
2024-1102.5
2024-1201.86
2025-0103.5
2025-0203.87
2025-0303
2025-0402.82
2025-0505.6
2025-0601.53
2025-0703.42
2025-0802.58
2025-0902.27
2025-1003.08
2025-1102.42
2025-1202.13
2026-0102.7
2026-0201.89
2026-0303
2026-0402.91
2026-0503.25
2026-0602.82
This device (reports/month)Average device in HTN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K203595 — cites (transitively): K133842 (d1), K153338 (d1), K153575 (d1), K973309 (d2), K021556 (d2), K063298 (d2), K081510 (d2), K112737 (d2), K151021 (d2), K962011 (d2), K963172 (d2), K963192 (d2), K153180 (d2), K050636 (d3), K062863 (d3), K954330 (d3) — cited as predicate by K252699, K254110

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

Manufacturer compliance record — Medshape, Inc.

  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2026-02-13 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2019-04-16 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2015-05-21 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations
  • NAI 2010-12-03 Medshape, INC. · 0 citations