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Redondo-L™

Model 36-5612 · Seaspine Orthopedics Corporation · DI 10889981035327

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

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

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 1.59/device2019-02: 0 reports for this device; peer average 1.26/device2019-03: 0 reports for this device; peer average 1.76/device2019-04: 0 reports for this device; peer average 1.41/device2019-05: 0 reports for this device; peer average 1.59/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 1.59/device2019-08: 0 reports for this device; peer average 1.4/device2019-09: 0 reports for this device; peer average 1.3/device2019-10: 0 reports for this device; peer average 1.77/device2019-11: 0 reports for this device; peer average 1.52/device2019-12: 0 reports for this device; peer average 1.44/device2020-01: 0 reports for this device; peer average 1.65/device2020-02: 0 reports for this device; peer average 1.63/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.39/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 1.74/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.58/device2020-09: 0 reports for this device; peer average 2.26/device2020-10: 0 reports for this device; peer average 1.9/device2020-11: 0 reports for this device; peer average 1.76/device2020-12: 0 reports for this device; peer average 1.65/device2021-01: 0 reports for this device; peer average 1.56/device2021-02: 0 reports for this device; peer average 1.58/device2021-03: 0 reports for this device; peer average 1.92/device2021-04: 0 reports for this device; peer average 1.52/device2021-05: 0 reports for this device; peer average 1.48/device2021-06: 0 reports for this device; peer average 2.39/device2021-07: 0 reports for this device; peer average 1.68/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.66/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.77/device2021-12: 0 reports for this device; peer average 2.15/device2022-01: 0 reports for this device; peer average 2.59/device2022-02: 0 reports for this device; peer average 2.21/device2022-03: 0 reports for this device; peer average 1.74/device2022-04: 0 reports for this device; peer average 1.73/device2022-05: 0 reports for this device; peer average 2.04/device2022-06: 0 reports for this device; peer average 1.76/device2022-07: 0 reports for this device; peer average 1.96/device2022-08: 0 reports for this device; peer average 1.76/device2022-09: 0 reports for this device; peer average 1.88/device2022-10: 0 reports for this device; peer average 1.7/device2022-11: 0 reports for this device; peer average 1.91/device2022-12: 0 reports for this device; peer average 1.62/device2023-01: 0 reports for this device; peer average 2.39/device2023-02: 0 reports for this device; peer average 1.94/device2023-03: 0 reports for this device; peer average 1.95/device2023-04: 0 reports for this device; peer average 1.71/device2023-05: 0 reports for this device; peer average 1.79/device2023-06: 0 reports for this device; peer average 1.68/device2023-07: 0 reports for this device; peer average 2.03/device2023-08: 0 reports for this device; peer average 1.71/device2023-09: 0 reports for this device; peer average 1.89/device2023-10: 0 reports for this device; peer average 1.81/device2023-11: 0 reports for this device; peer average 8.19/device2023-12: 0 reports for this device; peer average 3.09/device2024-01: 0 reports for this device; peer average 1.85/device2024-02: 0 reports for this device; peer average 2.05/device2024-03: 0 reports for this device; peer average 1.92/device2024-04: 0 reports for this device; peer average 1.41/device2024-05: 0 reports for this device; peer average 1.7/device2024-06: 0 reports for this device; peer average 1.73/device2024-07: 0 reports for this device; peer average 1.84/device2024-08: 0 reports for this device; peer average 1.87/device2024-09: 0 reports for this device; peer average 1.83/device2024-10: 0 reports for this device; peer average 1.93/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.73/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 2.02/device2025-04: 0 reports for this device; peer average 1.61/device2025-05: 0 reports for this device; peer average 1.88/device2025-06: 0 reports for this device; peer average 1.91/device2025-07: 0 reports for this device; peer average 1.72/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 1.58/device2025-10: 0 reports for this device; peer average 1.68/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 1.78/device2026-01: 0 reports for this device; peer average 1.78/device2026-02: 0 reports for this device; peer average 1.47/device2026-03: 0 reports for this device; peer average 2.45/device2026-04: 0 reports for this device; peer average 1.65/device2026-05: 0 reports for this device; peer average 1.6/device2026-06: 0 reports for this device; peer average 1.63/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.59
2019-0201.26
2019-0301.76
2019-0401.41
2019-0501.59
2019-0601.67
2019-0701.59
2019-0801.4
2019-0901.3
2019-1001.77
2019-1101.52
2019-1201.44
2020-0101.65
2020-0201.63
2020-0301.45
2020-0401.39
2020-0501.5
2020-0601.74
2020-0702
2020-0801.58
2020-0902.26
2020-1001.9
2020-1101.76
2020-1201.65
2021-0101.56
2021-0201.58
2021-0301.92
2021-0401.52
2021-0501.48
2021-0602.39
2021-0701.68
2021-0802
2021-0901.66
2021-1002
2021-1101.77
2021-1202.15
2022-0102.59
2022-0202.21
2022-0301.74
2022-0401.73
2022-0502.04
2022-0601.76
2022-0701.96
2022-0801.76
2022-0901.88
2022-1001.7
2022-1101.91
2022-1201.62
2023-0102.39
2023-0201.94
2023-0301.95
2023-0401.71
2023-0501.79
2023-0601.68
2023-0702.03
2023-0801.71
2023-0901.89
2023-1001.81
2023-1108.19
2023-1203.09
2024-0101.85
2024-0202.05
2024-0301.92
2024-0401.41
2024-0501.7
2024-0601.73
2024-0701.84
2024-0801.87
2024-0901.83
2024-1001.93
2024-1101.67
2024-1201.63
2025-0101.73
2025-0201.68
2025-0302.02
2025-0401.61
2025-0501.88
2025-0601.91
2025-0701.72
2025-0801.63
2025-0901.58
2025-1001.68
2025-1101.87
2025-1201.78
2026-0101.78
2026-0201.47
2026-0302.45
2026-0401.65
2026-0501.6
2026-0601.63
This device (reports/month)Average device in MAX, MQP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K103297 — cited as predicate by K142488

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