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Shoreline ACS

Model 85-0210 · Seaspine Orthopedics Corporation · DI 10889981124052

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

K161081 — cites (transitively): K092521 (d1), K142488 (d1), K150053 (d1), K151939 (d1), K082309 (d2), K082310 (d2), K082712 (d2), K102026 (d2), K103297 (d2), K112986 (d2), K083389 (d2), K113559 (d2), K131449 (d2), K080822 (d3), K091088 (d3) — cited as predicate by K170569, K183083, K190655, K201073, K212904, K213359

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