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UNIPLATE

Model 189721022 · DEPUY SPINE, LLC · DI 10705034181172

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

UDILibrary device dossier · generated 2026-09-15 · 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 2.12/device2019-02: 0 reports for this device; peer average 1.9/device2019-03: 0 reports for this device; peer average 1.84/device2019-04: 0 reports for this device; peer average 1.84/device2019-05: 0 reports for this device; peer average 1.96/device2019-06: 0 reports for this device; peer average 2.04/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 2.78/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 2.18/device2019-12: 0 reports for this device; peer average 1.73/device2020-01: 0 reports for this device; peer average 2.71/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.97/device2020-04: 0 reports for this device; peer average 1.68/device2020-05: 0 reports for this device; peer average 2.18/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 2.04/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 2.24/device2020-10: 0 reports for this device; peer average 2.51/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 1.76/device2021-02: 0 reports for this device; peer average 1.85/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 1.96/device2021-05: 0 reports for this device; peer average 1.87/device2021-06: 0 reports for this device; peer average 2.03/device2021-07: 0 reports for this device; peer average 2.25/device2021-08: 0 reports for this device; peer average 2.25/device2021-09: 0 reports for this device; peer average 1.87/device2021-10: 0 reports for this device; peer average 2.7/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.52/device2022-01: 0 reports for this device; peer average 2.3/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 1.81/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 1.97/device2022-06: 0 reports for this device; peer average 2.16/device2022-07: 0 reports for this device; peer average 3.4/device2022-08: 0 reports for this device; peer average 2.29/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 1.62/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2.12/device2023-01: 0 reports for this device; peer average 2.03/device2023-02: 0 reports for this device; peer average 2.15/device2023-03: 0 reports for this device; peer average 2.21/device2023-04: 0 reports for this device; peer average 1.78/device2023-05: 0 reports for this device; peer average 1.98/device2023-06: 0 reports for this device; peer average 1.59/device2023-07: 0 reports for this device; peer average 1.94/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 2.39/device2023-11: 0 reports for this device; peer average 2.36/device2023-12: 0 reports for this device; peer average 1.81/device2024-01: 0 reports for this device; peer average 2.36/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 3.6/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 3.02/device2024-06: 0 reports for this device; peer average 3.55/device2024-07: 0 reports for this device; peer average 2.16/device2024-08: 0 reports for this device; peer average 1.76/device2024-09: 0 reports for this device; peer average 2.97/device2024-10: 0 reports for this device; peer average 2.23/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.65/device2025-01: 0 reports for this device; peer average 2.26/device2025-02: 0 reports for this device; peer average 2.53/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 2.2/device2025-05: 0 reports for this device; peer average 2.74/device2025-06: 0 reports for this device; peer average 2.34/device2025-07: 0 reports for this device; peer average 2.03/device2025-08: 0 reports for this device; peer average 2.03/device2025-09: 0 reports for this device; peer average 2.04/device2025-10: 0 reports for this device; peer average 1.93/device2025-11: 0 reports for this device; peer average 1.98/device2025-12: 0 reports for this device; peer average 2.65/device2026-01: 0 reports for this device; peer average 2.69/device2026-02: 0 reports for this device; peer average 2.47/device2026-03: 0 reports for this device; peer average 2.83/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.46/device2026-06: 0 reports for this device; peer average 4.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.12
2019-0201.9
2019-0301.84
2019-0401.84
2019-0501.96
2019-0602.04
2019-0701.75
2019-0802.78
2019-0901.73
2019-1002.06
2019-1102.18
2019-1201.73
2020-0102.71
2020-0202.04
2020-0301.97
2020-0401.68
2020-0502.18
2020-0602.14
2020-0702.04
2020-0801.9
2020-0902.24
2020-1002.51
2020-1102.69
2020-1202.07
2021-0101.76
2021-0201.85
2021-0302.31
2021-0401.96
2021-0501.87
2021-0602.03
2021-0702.25
2021-0802.25
2021-0901.87
2021-1002.7
2021-1102.1
2021-1202.52
2022-0102.3
2022-0202.14
2022-0301.81
2022-0401.75
2022-0501.97
2022-0602.16
2022-0703.4
2022-0802.29
2022-0902.82
2022-1001.62
2022-1102.09
2022-1202.12
2023-0102.03
2023-0202.15
2023-0302.21
2023-0401.78
2023-0501.98
2023-0601.59
2023-0701.94
2023-0801.36
2023-0902.61
2023-1002.39
2023-1102.36
2023-1201.81
2024-0102.36
2024-0202.13
2024-0303.6
2024-0401.66
2024-0503.02
2024-0603.55
2024-0702.16
2024-0801.76
2024-0902.97
2024-1002.23
2024-1101.69
2024-1201.65
2025-0102.26
2025-0202.53
2025-0302.33
2025-0402.2
2025-0502.74
2025-0602.34
2025-0702.03
2025-0802.03
2025-0902.04
2025-1001.93
2025-1101.98
2025-1202.65
2026-0102.69
2026-0202.47
2026-0302.83
2026-0402
2026-0502.46
2026-0604.37
This device (reports/month)Average device in KWQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K082273 — cited as predicate by K112724, K121514, K132324, K151553, K160522, K160702, K171439, K181471, K192494

K171439 — cites (transitively): K013877 (d1), K042544 (d1), K052552 (d1), K070994 (d1), K072546 (d1), K080191 (d1), K082273 (d1), K100070 (d1), K103491 (d1), K112724 (d1)

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

Manufacturer compliance record — DEPUY SPINE, LLC

  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-03-06 Depuy Spine Inc · 0 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations