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Vu aPod™ - L

Model 31-22-1055 · Seaspine Orthopedics Corporation · DI 10889981046453

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

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-06 · 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 1.52/device2019-02: 0 reports for this device; peer average 1.3/device2019-03: 0 reports for this device; peer average 1.72/device2019-04: 0 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.62/device2019-07: 0 reports for this device; peer average 1.61/device2019-08: 0 reports for this device; peer average 1.35/device2019-09: 0 reports for this device; peer average 1.66/device2019-10: 0 reports for this device; peer average 1.97/device2019-11: 0 reports for this device; peer average 1.55/device2019-12: 0 reports for this device; peer average 1.44/device2020-01: 0 reports for this device; peer average 1.69/device2020-02: 0 reports for this device; peer average 1.85/device2020-03: 0 reports for this device; peer average 1.52/device2020-04: 0 reports for this device; peer average 1.4/device2020-05: 0 reports for this device; peer average 1.59/device2020-06: 0 reports for this device; peer average 2.1/device2020-07: 0 reports for this device; peer average 2.24/device2020-08: 0 reports for this device; peer average 1.58/device2020-09: 0 reports for this device; peer average 2.78/device2020-10: 0 reports for this device; peer average 2.16/device2020-11: 0 reports for this device; peer average 2.38/device2020-12: 0 reports for this device; peer average 1.64/device2021-01: 0 reports for this device; peer average 1.81/device2021-02: 0 reports for this device; peer average 1.76/device2021-03: 0 reports for this device; peer average 1.94/device2021-04: 0 reports for this device; peer average 1.63/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.36/device2021-07: 0 reports for this device; peer average 1.83/device2021-08: 0 reports for this device; peer average 2.35/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 1.91/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 3.24/device2022-02: 0 reports for this device; peer average 2.85/device2022-03: 0 reports for this device; peer average 1.82/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.28/device2022-06: 0 reports for this device; peer average 1.74/device2022-07: 0 reports for this device; peer average 2.14/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 1.88/device2022-10: 0 reports for this device; peer average 1.84/device2022-11: 0 reports for this device; peer average 1.86/device2022-12: 0 reports for this device; peer average 1.67/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 0 reports for this device; peer average 1.96/device2023-03: 0 reports for this device; peer average 1.72/device2023-04: 0 reports for this device; peer average 1.87/device2023-05: 0 reports for this device; peer average 1.91/device2023-06: 0 reports for this device; peer average 1.64/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.9/device2023-10: 0 reports for this device; peer average 1.73/device2023-11: 0 reports for this device; peer average 8.42/device2023-12: 0 reports for this device; peer average 3.45/device2024-01: 0 reports for this device; peer average 1.87/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 1.84/device2024-04: 0 reports for this device; peer average 1.46/device2024-05: 0 reports for this device; peer average 1.76/device2024-06: 0 reports for this device; peer average 1.81/device2024-07: 0 reports for this device; peer average 1.97/device2024-08: 0 reports for this device; peer average 2.19/device2024-09: 0 reports for this device; peer average 1.87/device2024-10: 0 reports for this device; peer average 2.1/device2024-11: 0 reports for this device; peer average 1.76/device2024-12: 0 reports for this device; peer average 1.82/device2025-01: 0 reports for this device; peer average 1.82/device2025-02: 0 reports for this device; peer average 1.63/device2025-03: 0 reports for this device; peer average 1.64/device2025-04: 0 reports for this device; peer average 1.59/device2025-05: 0 reports for this device; peer average 1.64/device2025-06: 0 reports for this device; peer average 1.96/device2025-07: 0 reports for this device; peer average 1.95/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.68/device2025-10: 0 reports for this device; peer average 1.72/device2025-11: 0 reports for this device; peer average 1.91/device2025-12: 0 reports for this device; peer average 1.83/device2026-01: 0 reports for this device; peer average 1.83/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2.67/device2026-04: 0 reports for this device; peer average 1.6/device2026-05: 0 reports for this device; peer average 1.57/device2026-06: 0 reports for this device; peer average 1.62/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.52
2019-0201.3
2019-0301.72
2019-0401.4
2019-0501.56
2019-0601.62
2019-0701.61
2019-0801.35
2019-0901.66
2019-1001.97
2019-1101.55
2019-1201.44
2020-0101.69
2020-0201.85
2020-0301.52
2020-0401.4
2020-0501.59
2020-0602.1
2020-0702.24
2020-0801.58
2020-0902.78
2020-1002.16
2020-1102.38
2020-1201.64
2021-0101.81
2021-0201.76
2021-0301.94
2021-0401.63
2021-0502
2021-0602.36
2021-0701.83
2021-0802.35
2021-0901.72
2021-1002.27
2021-1101.91
2021-1202.72
2022-0103.24
2022-0202.85
2022-0301.82
2022-0401.76
2022-0502.28
2022-0601.74
2022-0702.14
2022-0802.07
2022-0901.88
2022-1001.84
2022-1101.86
2022-1201.67
2023-0102.27
2023-0201.96
2023-0301.72
2023-0401.87
2023-0501.91
2023-0601.64
2023-0702
2023-0801.7
2023-0901.9
2023-1001.73
2023-1108.42
2023-1203.45
2024-0101.87
2024-0202.08
2024-0301.84
2024-0401.46
2024-0501.76
2024-0601.81
2024-0701.97
2024-0802.19
2024-0901.87
2024-1002.1
2024-1101.76
2024-1201.82
2025-0101.82
2025-0201.63
2025-0301.64
2025-0401.59
2025-0501.64
2025-0601.96
2025-0701.95
2025-0801.61
2025-0901.68
2025-1001.72
2025-1101.91
2025-1201.83
2026-0101.83
2026-0201.5
2026-0302.67
2026-0401.6
2026-0501.57
2026-0601.62
This device (reports/month)Average device in MAX, OVD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112986 — cites (transitively): K080822 (d1) — cited as predicate by K142488, K181079

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

Manufacturer compliance record — Seaspine Orthopedics Corporation

  • Warning Letter 2026-02-24 IsoTis OrthoBiologics, Inc.
  • OAI 2025-10-17 IsoTis OrthoBiologics, Inc. · 3 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2015-09-25 IsoTis OrthoBiologics, Inc. · 0 citations
  • NAI 2012-04-27 IsoTis OrthoBiologics, Inc. · 0 citations