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SUMMIT

Model 174617750 · DEPUY SPINE, LLC · DI 10705034021706

KWP — Appliance, Fixation, Spinal Interlaminal · Class II · 21 CFR 888.3050

MNI — Orthosis, Spinal Pedicle Fixation · Class II · 21 CFR 888.3070

NKG — Posterior Cervical Screw System · Class II · 21 CFR 888.3075

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.

24682019-01: 0 reports for this device; peer average 2.08/device2019-02: 0 reports for this device; peer average 1.9/device2019-03: 0 reports for this device; peer average 1.96/device2019-04: 0 reports for this device; peer average 2.03/device2019-05: 0 reports for this device; peer average 2.16/device2019-06: 0 reports for this device; peer average 2.43/device2019-07: 0 reports for this device; peer average 1.64/device2019-08: 0 reports for this device; peer average 2.6/device2019-09: 0 reports for this device; peer average 1.8/device2019-10: 0 reports for this device; peer average 1.81/device2019-11: 0 reports for this device; peer average 2.13/device2019-12: 0 reports for this device; peer average 1.65/device2020-01: 0 reports for this device; peer average 2.53/device2020-02: 0 reports for this device; peer average 2.38/device2020-03: 0 reports for this device; peer average 2.32/device2020-04: 0 reports for this device; peer average 1.52/device2020-05: 0 reports for this device; peer average 2.16/device2020-06: 0 reports for this device; peer average 2.04/device2020-07: 0 reports for this device; peer average 1.73/device2020-08: 0 reports for this device; peer average 1.83/device2020-09: 0 reports for this device; peer average 2.31/device2020-10: 0 reports for this device; peer average 2.41/device2020-11: 0 reports for this device; peer average 2.24/device2020-12: 0 reports for this device; peer average 2.05/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 1.89/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 2.14/device2021-05: 0 reports for this device; peer average 1.99/device2021-06: 0 reports for this device; peer average 1.85/device2021-07: 0 reports for this device; peer average 7.96/device2021-08: 0 reports for this device; peer average 1.98/device2021-09: 0 reports for this device; peer average 1.7/device2021-10: 0 reports for this device; peer average 2.41/device2021-11: 0 reports for this device; peer average 2.04/device2021-12: 0 reports for this device; peer average 2.12/device2022-01: 0 reports for this device; peer average 2.05/device2022-02: 0 reports for this device; peer average 1.88/device2022-03: 0 reports for this device; peer average 1.82/device2022-04: 0 reports for this device; peer average 1.89/device2022-05: 0 reports for this device; peer average 1.71/device2022-06: 0 reports for this device; peer average 2.03/device2022-07: 0 reports for this device; peer average 3.3/device2022-08: 0 reports for this device; peer average 2/device2022-09: 0 reports for this device; peer average 2.78/device2022-10: 0 reports for this device; peer average 1.46/device2022-11: 0 reports for this device; peer average 1.87/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.74/device2023-02: 0 reports for this device; peer average 1.86/device2023-03: 0 reports for this device; peer average 1.96/device2023-04: 0 reports for this device; peer average 2.02/device2023-05: 0 reports for this device; peer average 1.81/device2023-06: 0 reports for this device; peer average 1.7/device2023-07: 0 reports for this device; peer average 1.85/device2023-08: 0 reports for this device; peer average 1.51/device2023-09: 0 reports for this device; peer average 2.72/device2023-10: 0 reports for this device; peer average 2.56/device2023-11: 0 reports for this device; peer average 2.35/device2023-12: 0 reports for this device; peer average 1.63/device2024-01: 0 reports for this device; peer average 2.44/device2024-02: 0 reports for this device; peer average 2.1/device2024-03: 0 reports for this device; peer average 3.74/device2024-04: 0 reports for this device; peer average 1.74/device2024-05: 0 reports for this device; peer average 3.33/device2024-06: 0 reports for this device; peer average 1.99/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 1.94/device2024-09: 0 reports for this device; peer average 2.28/device2024-10: 0 reports for this device; peer average 2.17/device2024-11: 0 reports for this device; peer average 2.07/device2024-12: 0 reports for this device; peer average 1.76/device2025-01: 0 reports for this device; peer average 2.31/device2025-02: 0 reports for this device; peer average 2.39/device2025-03: 0 reports for this device; peer average 2.23/device2025-04: 0 reports for this device; peer average 2.24/device2025-05: 0 reports for this device; peer average 2.22/device2025-06: 0 reports for this device; peer average 2.36/device2025-07: 0 reports for this device; peer average 2.2/device2025-08: 0 reports for this device; peer average 1.88/device2025-09: 0 reports for this device; peer average 1.91/device2025-10: 0 reports for this device; peer average 2.01/device2025-11: 0 reports for this device; peer average 1.95/device2025-12: 0 reports for this device; peer average 2.24/device2026-01: 0 reports for this device; peer average 2.52/device2026-02: 0 reports for this device; peer average 2.41/device2026-03: 0 reports for this device; peer average 2.51/device2026-04: 0 reports for this device; peer average 1.81/device2026-05: 0 reports for this device; peer average 2.11/device2026-06: 0 reports for this device; peer average 4.42/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.08
2019-0201.9
2019-0301.96
2019-0402.03
2019-0502.16
2019-0602.43
2019-0701.64
2019-0802.6
2019-0901.8
2019-1001.81
2019-1102.13
2019-1201.65
2020-0102.53
2020-0202.38
2020-0302.32
2020-0401.52
2020-0502.16
2020-0602.04
2020-0701.73
2020-0801.83
2020-0902.31
2020-1002.41
2020-1102.24
2020-1202.05
2021-0102.13
2021-0201.89
2021-0302.31
2021-0402.14
2021-0501.99
2021-0601.85
2021-0707.96
2021-0801.98
2021-0901.7
2021-1002.41
2021-1102.04
2021-1202.12
2022-0102.05
2022-0201.88
2022-0301.82
2022-0401.89
2022-0501.71
2022-0602.03
2022-0703.3
2022-0802
2022-0902.78
2022-1001.46
2022-1101.87
2022-1202
2023-0101.74
2023-0201.86
2023-0301.96
2023-0402.02
2023-0501.81
2023-0601.7
2023-0701.85
2023-0801.51
2023-0902.72
2023-1002.56
2023-1102.35
2023-1201.63
2024-0102.44
2024-0202.1
2024-0303.74
2024-0401.74
2024-0503.33
2024-0601.99
2024-0701.9
2024-0801.94
2024-0902.28
2024-1002.17
2024-1102.07
2024-1201.76
2025-0102.31
2025-0202.39
2025-0302.23
2025-0402.24
2025-0502.22
2025-0602.36
2025-0702.2
2025-0801.88
2025-0901.91
2025-1002.01
2025-1101.95
2025-1202.24
2026-0102.52
2026-0202.41
2026-0302.51
2026-0401.81
2026-0502.11
2026-0604.42
This device (reports/month)Average device in KWP, MNI, NKG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K030103 — cited as predicate by K181350

K151885 — cites (transitively): K042508 (d1), K132332 (d1), K142838 (d1), K041203 (d2), K080828 (d2), K110353 (d2), K062254 (d2) — cited as predicate by K150474, K153370, K161498, K172139, K181350, K181949, K190895, K192013, K192646, K200571, K203319

K190895 — cites (transitively): K151885 (d1), K181949 (d1), K963350 (d1), K980368 (d1), K982483 (d1), K042508 (d2), K132332 (d2), K142838 (d2), K041203 (d3), K080828 (d3), K110353 (d3), K062254 (d3) — cited as predicate by K192014, K192646, K200936, K203319, K253195

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