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

Leva® Spacer System

Model 10-7242.1 · Spine Wave, Inc. · DI 10840642117370

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080

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.

358102019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 0 reports for this device; peer average 1.69/device2019-04: 0 reports for this device; peer average 1.46/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 1.65/device2019-08: 0 reports for this device; peer average 1.36/device2019-09: 0 reports for this device; peer average 1.32/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 1.58/device2019-12: 0 reports for this device; peer average 1.36/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.73/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.64/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.05/device2020-11: 0 reports for this device; peer average 2.1/device2020-12: 0 reports for this device; peer average 1.76/device2021-01: 0 reports for this device; peer average 1.7/device2021-02: 0 reports for this device; peer average 1.72/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.55/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 1.73/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.84/device2021-12: 0 reports for this device; peer average 2.54/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 0 reports for this device; peer average 1.78/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.79/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.7/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 0 reports for this device; peer average 1.81/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.85/device2023-11: 0 reports for this device; peer average 10.03/device2023-12: 0 reports for this device; peer average 3.95/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 1.58/device2024-06: 0 reports for this device; peer average 1.79/device2024-07: 0 reports for this device; peer average 1.93/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.9/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.66/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.59/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.76/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.22
2019-0301.69
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.65
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.36
2020-0101.67
2020-0201.73
2020-0301.45
2020-0401.43
2020-0501.64
2020-0601.84
2020-0701.85
2020-0801.63
2020-0902.52
2020-1002.05
2020-1102.1
2020-1201.76
2021-0101.7
2021-0201.72
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.72
2021-1002.11
2021-1101.84
2021-1202.54
2022-0103.14
2022-0202.62
2022-0301.78
2022-0401.76
2022-0502.13
2022-0601.79
2022-0702.21
2022-0801.86
2022-0901.78
2022-1001.87
2022-1101.93
2022-1201.7
2023-0102.44
2023-0202.05
2023-0301.71
2023-0401.81
2023-0502.04
2023-0601.75
2023-0702.04
2023-0801.73
2023-0901.97
2023-1001.85
2023-11010.03
2023-1203.95
2024-0101.86
2024-0202.13
2024-0301.9
2024-0401.36
2024-0501.58
2024-0601.79
2024-0701.93
2024-0802.27
2024-0901.9
2024-1002.13
2024-1101.74
2024-1201.69
2025-0101.85
2025-0201.66
2025-0301.66
2025-0401.6
2025-0501.65
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.59
2025-1001.71
2025-1102.03
2025-1201.85
2026-0101.94
2026-0201.53
2026-0302.76
2026-0401.57
2026-0501.58
2026-0601.6
This device (reports/month)Average device in MAX (reports/device/month)

Regulatory clearances

  • K153222 SESE 2016-04-15 (k number procode)

Predicate lineage

K153222 — cites (transitively): K122097 (d1), K151581 (d1), K152620 (d1), K072970 (d2), K093242 (d2), K113447 (d2), K141980 (d2), K150285 (d2), K103814 (d2), K113285 (d2), K123231 (d2), K123461 (d2), K131071 (d2), K132719 (d2), K140007 (d2), K141791 (d2), K073470 (d3), K082014 (d3), K083661 (d3), K090166 (d3), P950019 (d3), P960025 (d3), K082262 (d3), K090507 (d3), K103382 (d3), K080537 (d3), K083626 (d3), K102293 (d3), K123767 (d3), K131547 (d3), K071795 (d4), K082252 (d4) — cited as predicate by K231275

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

Manufacturer compliance record — Spine Wave, Inc.

  • NAI 2026-04-21 Spine Wave, Inc. · 0 citations
  • NAI 2026-04-21 Spine Wave, Inc. · 0 citations
  • NAI 2023-04-25 Spine Wave, Inc. · 0 citations
  • NAI 2023-04-25 Spine Wave, Inc. · 0 citations
  • VAI 2017-01-10 Spine Wave, Inc. · 2 citations
  • VAI 2017-01-10 Spine Wave, Inc. · 2 citations
  • NAI 2013-05-24 Spine Wave, Inc. · 0 citations
  • NAI 2013-05-24 Spine Wave, Inc. · 0 citations