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Shoreline ACS

Model 86-2411 · Seaspine Orthopedics Corporation · DI 10889981144685

OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical · 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.

24682019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.25/device2019-07: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 1.2/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 8/device2020-02: 0 reports for this device; peer average 1.4/device2020-03: 0 reports for this device; peer average 1.2/device2020-04: 0 reports for this device; peer average 1.2/device2020-05: 0 reports for this device; peer average 1.33/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2.33/device2020-10: 0 reports for this device; peer average 1.63/device2020-11: 0 reports for this device; peer average 1.33/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1.25/device2021-02: 0 reports for this device; peer average 3.5/device2021-03: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 3.92/device2021-06: 0 reports for this device; peer average 1.25/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1.67/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.14/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1.4/device2022-06: 0 reports for this device; peer average 1.78/device2022-07: 0 reports for this device; peer average 1.14/device2022-08: 0 reports for this device; peer average 1.13/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1.33/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 0 reports for this device; peer average 3/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.83/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1.36/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 1.57/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.77/device2024-06: 0 reports for this device; peer average 3.38/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.2/device2024-09: 0 reports for this device; peer average 1.57/device2024-10: 0 reports for this device; peer average 1.5/device2024-11: 0 reports for this device; peer average 1.25/device2024-12: 0 reports for this device; peer average 1.25/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 2.2/device2025-03: 0 reports for this device; peer average 2.56/device2025-04: 0 reports for this device; peer average 1.75/device2025-05: 0 reports for this device; peer average 1.8/device2025-06: 0 reports for this device; peer average 2.4/device2025-07: 0 reports for this device; peer average 2.11/device2025-08: 0 reports for this device; peer average 1.4/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.57/device2025-11: 0 reports for this device; peer average 2.2/device2025-12: 0 reports for this device; peer average 1.4/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.71/device2026-03: 0 reports for this device; peer average 1.56/device2026-04: 0 reports for this device; peer average 1.25/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 3.5/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030405060708101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0302
2019-0401.71
2019-0501.56
2019-0601.25
2019-0701.67
2019-0803
2019-0901.67
2019-1002
2019-1101.2
2019-1201.5
2020-0108
2020-0201.4
2020-0301.2
2020-0401.2
2020-0501.33
2020-0601
2020-0702.17
2020-0801
2020-0902.33
2020-1001.63
2020-1101.33
2020-1201.33
2021-0101.25
2021-0203.5
2021-0301.5
2021-0401
2021-0503.92
2021-0601.25
2021-0701
2021-0801.67
2021-0901.5
2021-1001
2021-1101
2021-1202
2022-0101
2022-0201
2022-0301.14
2022-0401
2022-0501.4
2022-0601.78
2022-0701.14
2022-0801.13
2022-0902
2022-1001
2022-1101.33
2022-1202.25
2023-0103
2023-0202
2023-0302.83
2023-0402
2023-0501.33
2023-0601.67
2023-0701.5
2023-0801.36
2023-1002
2023-1101
2023-1201.5
2024-0101.57
2024-0201.5
2024-0301.88
2024-0402
2024-0501.77
2024-0603.38
2024-0701
2024-0801.2
2024-0901.57
2024-1001.5
2024-1101.25
2024-1201.25
2025-0101.5
2025-0202.2
2025-0302.56
2025-0401.75
2025-0501.8
2025-0602.4
2025-0702.11
2025-0801.4
2025-0901.75
2025-1001.57
2025-1102.2
2025-1201.4
2026-0101.71
2026-0201.71
2026-0301.56
2026-0401.25
2026-0504
2026-0603.5
This device (reports/month)Average device in OVE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K170569 — cites (transitively): K151939 (d1), K161081 (d1), K162715 (d1), K083389 (d2), K113559 (d2), K131449 (d2), K150053 (d2), K092521 (d2), K142488 (d2), K091088 (d3), K082309 (d3), K082310 (d3), K082712 (d3), K102026 (d3), K103297 (d3), K112986 (d3), K080822 (d4) — cited as predicate by K183083, K190655, K211935, K212612

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