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Shoreline ACS

Model 85-2807 · Seaspine Orthopedics Corporation · DI 10889981276621

KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060

UDILibrary device dossier · generated 2026-09-11 · 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.

12342019-01: 0 reports for this device; peer average 2.12/device2019-02: 0 reports for this device; peer average 1.9/device2019-03: 0 reports for this device; peer average 1.84/device2019-04: 0 reports for this device; peer average 1.84/device2019-05: 0 reports for this device; peer average 1.96/device2019-06: 0 reports for this device; peer average 2.04/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 2.78/device2019-09: 0 reports for this device; peer average 1.73/device2019-10: 0 reports for this device; peer average 2.06/device2019-11: 0 reports for this device; peer average 2.18/device2019-12: 0 reports for this device; peer average 1.73/device2020-01: 0 reports for this device; peer average 2.71/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.97/device2020-04: 0 reports for this device; peer average 1.68/device2020-05: 0 reports for this device; peer average 2.18/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 2.04/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 2.24/device2020-10: 0 reports for this device; peer average 2.51/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 1.76/device2021-02: 0 reports for this device; peer average 1.85/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 1.96/device2021-05: 0 reports for this device; peer average 1.87/device2021-06: 0 reports for this device; peer average 2.03/device2021-07: 0 reports for this device; peer average 2.25/device2021-08: 0 reports for this device; peer average 2.25/device2021-09: 0 reports for this device; peer average 1.87/device2021-10: 0 reports for this device; peer average 2.7/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.52/device2022-01: 0 reports for this device; peer average 2.3/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 1.81/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 1.97/device2022-06: 0 reports for this device; peer average 2.16/device2022-07: 0 reports for this device; peer average 3.4/device2022-08: 0 reports for this device; peer average 2.29/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 1.62/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2.12/device2023-01: 0 reports for this device; peer average 2.03/device2023-02: 0 reports for this device; peer average 2.15/device2023-03: 0 reports for this device; peer average 2.21/device2023-04: 0 reports for this device; peer average 1.78/device2023-05: 0 reports for this device; peer average 1.98/device2023-06: 0 reports for this device; peer average 1.59/device2023-07: 0 reports for this device; peer average 1.94/device2023-08: 0 reports for this device; peer average 1.36/device2023-09: 0 reports for this device; peer average 2.61/device2023-10: 0 reports for this device; peer average 2.39/device2023-11: 0 reports for this device; peer average 2.36/device2023-12: 0 reports for this device; peer average 1.81/device2024-01: 0 reports for this device; peer average 2.36/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 3.6/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 3.02/device2024-06: 0 reports for this device; peer average 3.55/device2024-07: 0 reports for this device; peer average 2.16/device2024-08: 0 reports for this device; peer average 1.76/device2024-09: 0 reports for this device; peer average 2.97/device2024-10: 0 reports for this device; peer average 2.23/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.65/device2025-01: 0 reports for this device; peer average 2.26/device2025-02: 0 reports for this device; peer average 2.53/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 2.2/device2025-05: 0 reports for this device; peer average 2.74/device2025-06: 0 reports for this device; peer average 2.34/device2025-07: 0 reports for this device; peer average 2.03/device2025-08: 0 reports for this device; peer average 2.03/device2025-09: 0 reports for this device; peer average 2.04/device2025-10: 0 reports for this device; peer average 1.93/device2025-11: 0 reports for this device; peer average 1.98/device2025-12: 0 reports for this device; peer average 2.65/device2026-01: 0 reports for this device; peer average 2.69/device2026-02: 0 reports for this device; peer average 2.47/device2026-03: 0 reports for this device; peer average 2.83/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.46/device2026-06: 0 reports for this device; peer average 4.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.12
2019-0201.9
2019-0301.84
2019-0401.84
2019-0501.96
2019-0602.04
2019-0701.75
2019-0802.78
2019-0901.73
2019-1002.06
2019-1102.18
2019-1201.73
2020-0102.71
2020-0202.04
2020-0301.97
2020-0401.68
2020-0502.18
2020-0602.14
2020-0702.04
2020-0801.9
2020-0902.24
2020-1002.51
2020-1102.69
2020-1202.07
2021-0101.76
2021-0201.85
2021-0302.31
2021-0401.96
2021-0501.87
2021-0602.03
2021-0702.25
2021-0802.25
2021-0901.87
2021-1002.7
2021-1102.1
2021-1202.52
2022-0102.3
2022-0202.14
2022-0301.81
2022-0401.75
2022-0501.97
2022-0602.16
2022-0703.4
2022-0802.29
2022-0902.82
2022-1001.62
2022-1102.09
2022-1202.12
2023-0102.03
2023-0202.15
2023-0302.21
2023-0401.78
2023-0501.98
2023-0601.59
2023-0701.94
2023-0801.36
2023-0902.61
2023-1002.39
2023-1102.36
2023-1201.81
2024-0102.36
2024-0202.13
2024-0303.6
2024-0401.66
2024-0503.02
2024-0603.55
2024-0702.16
2024-0801.76
2024-0902.97
2024-1002.23
2024-1101.69
2024-1201.65
2025-0102.26
2025-0202.53
2025-0302.33
2025-0402.2
2025-0502.74
2025-0602.34
2025-0702.03
2025-0802.03
2025-0902.04
2025-1001.93
2025-1101.98
2025-1202.65
2026-0102.69
2026-0202.47
2026-0302.83
2026-0402
2026-0502.46
2026-0604.37
This device (reports/month)Average device in KWQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K211903 — cites (transitively): K173521 (d1), K190885 (d1), K202064 (d1), K142060 (d2), K142218 (d2), K173115 (d2), K112206 (d2), K032368 (d3), K083338 (d3), K012184 (d3), K030595 (d3), K050892 (d3), K100614 (d3), K120515 (d3), K131374 (d3), K974885 (d3), K143578 (d3), K151939 (d3), K152022 (d3), K161442 (d3), K163491 (d3), K073479 (d4), K012305 (d4), K030866 (d4), K040284 (d4), K060665 (d4), K072465 (d4), K072970 (d4), K072991 (d4), K082252 (d4), K083389 (d4), K093242 (d4), K102293 (d4), K102313 (d4), K112756 (d4), K120101 (d4), K121107 (d4), K122097 (d4), K123231 (d4), K130478 (d4), K131449 (d4), K133967 (d4), K113559 (d4), K150053 (d4), K081611 (d4), K102547 (d4), K131025 (d4), K140921 (d4), K142299 (d4), K150362 (d4), K003275 (d5), K041389 (d5), K050850 (d5), K060506 (d5), K091088 (d5), K090841 (d5), K113447 (d5), K080537 (d5), K031302 (d5), P980048 (d5), K000536 (d5), K053581 (d5), K130573 (d5), K092521 (d5), K132894 (d5), K140003 (d5), K142050 (d5), K142264 (d5), K072791 (d6), K081917 (d6), K073351 (d6), K103033 (d6), K111119 (d6), K112388 (d6), K120345 (d6), K123206 (d6), K130177 (d6), K070754 (d7), P000028 (d7), K094042 (d7), K042571 (d7), K050624 (d7), K061836 (d7), K062132 (d7), K082014 (d7), P960025 (d7), K043479 (d7) — cited as predicate by K233640

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