Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Unnamed device

Model 04.614.520 · Synthes GmbH · DI 10705034739342

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

MNH — Orthosis, Spondylolisthesis Spinal Fixation · Class II · 21 CFR 888.3070

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 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2019-09-16Z-0223-2020Class IITerminatedThe subject product measures 4.0mm in diameter instead of 3.5mm.k number procode

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 1.98/device2019-04: 0 reports for this device; peer average 2.03/device2019-05: 0 reports for this device; peer average 2.23/device2019-06: 0 reports for this device; peer average 2.54/device2019-07: 0 reports for this device; peer average 1.66/device2019-08: 0 reports for this device; peer average 2.71/device2019-09: 0 reports for this device; peer average 1.78/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 2.17/device2019-12: 0 reports for this device; peer average 1.64/device2020-01: 0 reports for this device; peer average 2.5/device2020-02: 0 reports for this device; peer average 2.3/device2020-03: 0 reports for this device; peer average 2.25/device2020-04: 0 reports for this device; peer average 1.56/device2020-05: 0 reports for this device; peer average 2.21/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.75/device2020-08: 0 reports for this device; peer average 1.86/device2020-09: 0 reports for this device; peer average 2.31/device2020-10: 0 reports for this device; peer average 2.46/device2020-11: 0 reports for this device; peer average 2.28/device2020-12: 0 reports for this device; peer average 2.06/device2021-01: 0 reports for this device; peer average 2.17/device2021-02: 0 reports for this device; peer average 1.89/device2021-03: 0 reports for this device; peer average 2.37/device2021-04: 0 reports for this device; peer average 2.19/device2021-05: 0 reports for this device; peer average 1.98/device2021-06: 0 reports for this device; peer average 1.82/device2021-07: 0 reports for this device; peer average 7.94/device2021-08: 0 reports for this device; peer average 1.96/device2021-09: 0 reports for this device; peer average 1.7/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 2.15/device2021-12: 0 reports for this device; peer average 2.19/device2022-01: 0 reports for this device; peer average 2.1/device2022-02: 0 reports for this device; peer average 1.89/device2022-03: 0 reports for this device; peer average 1.83/device2022-04: 0 reports for this device; peer average 1.95/device2022-05: 0 reports for this device; peer average 1.75/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 3.46/device2022-08: 0 reports for this device; peer average 1.97/device2022-09: 0 reports for this device; peer average 2.78/device2022-10: 0 reports for this device; peer average 1.44/device2022-11: 0 reports for this device; peer average 1.89/device2022-12: 0 reports for this device; peer average 2.01/device2023-01: 0 reports for this device; peer average 1.69/device2023-02: 0 reports for this device; peer average 1.83/device2023-03: 0 reports for this device; peer average 1.93/device2023-04: 0 reports for this device; peer average 2.02/device2023-05: 0 reports for this device; peer average 1.74/device2023-06: 0 reports for this device; peer average 1.72/device2023-07: 0 reports for this device; peer average 1.86/device2023-08: 0 reports for this device; peer average 1.48/device2023-09: 0 reports for this device; peer average 2.78/device2023-10: 0 reports for this device; peer average 2.64/device2023-11: 0 reports for this device; peer average 2.49/device2023-12: 0 reports for this device; peer average 1.62/device2024-01: 0 reports for this device; peer average 2.46/device2024-02: 0 reports for this device; peer average 2.12/device2024-03: 0 reports for this device; peer average 3.82/device2024-04: 0 reports for this device; peer average 1.76/device2024-05: 0 reports for this device; peer average 3.37/device2024-06: 0 reports for this device; peer average 1.91/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2.21/device2024-10: 0 reports for this device; peer average 2.07/device2024-11: 0 reports for this device; peer average 2.17/device2024-12: 0 reports for this device; peer average 1.75/device2025-01: 0 reports for this device; peer average 2.28/device2025-02: 0 reports for this device; peer average 2.39/device2025-03: 0 reports for this device; peer average 2.3/device2025-04: 0 reports for this device; peer average 2.29/device2025-05: 0 reports for this device; peer average 2.12/device2025-06: 0 reports for this device; peer average 2.25/device2025-07: 0 reports for this device; peer average 2.07/device2025-08: 0 reports for this device; peer average 1.87/device2025-09: 0 reports for this device; peer average 1.92/device2025-10: 0 reports for this device; peer average 2.04/device2025-11: 0 reports for this device; peer average 1.95/device2025-12: 0 reports for this device; peer average 2.23/device2026-01: 0 reports for this device; peer average 2.54/device2026-02: 0 reports for this device; peer average 2.44/device2026-03: 0 reports for this device; peer average 2.56/device2026-04: 0 reports for this device; peer average 1.82/device2026-05: 0 reports for this device; peer average 1.99/device2026-06: 0 reports for this device; peer average 4.63/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
2019-0301.98
2019-0402.03
2019-0502.23
2019-0602.54
2019-0701.66
2019-0802.71
2019-0901.78
2019-1001.83
2019-1102.17
2019-1201.64
2020-0102.5
2020-0202.3
2020-0302.25
2020-0401.56
2020-0502.21
2020-0602
2020-0701.75
2020-0801.86
2020-0902.31
2020-1002.46
2020-1102.28
2020-1202.06
2021-0102.17
2021-0201.89
2021-0302.37
2021-0402.19
2021-0501.98
2021-0601.82
2021-0707.94
2021-0801.96
2021-0901.7
2021-1002.5
2021-1102.15
2021-1202.19
2022-0102.1
2022-0201.89
2022-0301.83
2022-0401.95
2022-0501.75
2022-0602.02
2022-0703.46
2022-0801.97
2022-0902.78
2022-1001.44
2022-1101.89
2022-1202.01
2023-0101.69
2023-0201.83
2023-0301.93
2023-0402.02
2023-0501.74
2023-0601.72
2023-0701.86
2023-0801.48
2023-0902.78
2023-1002.64
2023-1102.49
2023-1201.62
2024-0102.46
2024-0202.12
2024-0303.82
2024-0401.76
2024-0503.37
2024-0601.91
2024-0701.9
2024-0802
2024-0902.21
2024-1002.07
2024-1102.17
2024-1201.75
2025-0102.28
2025-0202.39
2025-0302.3
2025-0402.29
2025-0502.12
2025-0602.25
2025-0702.07
2025-0801.87
2025-0901.92
2025-1002.04
2025-1101.95
2025-1202.23
2026-0102.54
2026-0202.44
2026-0302.56
2026-0401.82
2026-0501.99
2026-0604.63
This device (reports/month)Average device in KWP, MNH, MNI, NKG (reports/device/month)

Regulatory clearances

  • K142838 SESE 2015-01-20 (k number procode)
  • K141897 SESE 2014-09-25 (k number procode)

Predicate lineage

K090549 — cited as predicate by K181350

K091689 — cited as predicate by K133556, K141897, K142460, K171250

K141897 — cites (transitively): K023675 (d1), K030377 (d1), K091689 (d1), K133698 (d1), K033961 (d2), K062934 (d2), K080526 (d2) — cited as predicate by K142867, K171250, K181350

K142460 — cites (transitively): K091689 (d1), K100634 (d1), K111136 (d1), K022949 (d2), K023675 (d2), K070573 (d2), K082572 (d2), K092929 (d2), K963045 (d2)

K142838 — cites (transitively): K062254 (d1) — cited as predicate by K150474, K150539, K150552, K150650, K150822, K151224, K151885, K151938, K152211, K160697, K161032, K161591, K161637, K162575, K170804, K171369, K171444, K171834, K172594, K180198, K181350, K181949, K182508, K182837, K192646, K203149, K203319, K233989

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