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SeaSpine Spacer System - Hollywood NanoMetalene

Model 93-4508 · Seaspine Orthopedics Corporation · DI 10889981129644

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

ODP — Intervertebral Fusion Device With Bone Graft, 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.

25792019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.19/device2019-03: 0 reports for this device; peer average 1.64/device2019-04: 0 reports for this device; peer average 1.42/device2019-05: 0 reports for this device; peer average 1.59/device2019-06: 0 reports for this device; peer average 1.51/device2019-07: 0 reports for this device; peer average 1.69/device2019-08: 0 reports for this device; peer average 2.18/device2019-09: 0 reports for this device; peer average 1.31/device2019-10: 0 reports for this device; peer average 2.23/device2019-11: 0 reports for this device; peer average 1.56/device2019-12: 0 reports for this device; peer average 1.34/device2020-01: 0 reports for this device; peer average 1.63/device2020-02: 0 reports for this device; peer average 1.74/device2020-03: 0 reports for this device; peer average 1.46/device2020-04: 0 reports for this device; peer average 1.45/device2020-05: 0 reports for this device; peer average 1.62/device2020-06: 0 reports for this device; peer average 1.74/device2020-07: 0 reports for this device; peer average 1.77/device2020-08: 0 reports for this device; peer average 1.54/device2020-09: 0 reports for this device; peer average 2.47/device2020-10: 0 reports for this device; peer average 1.94/device2020-11: 0 reports for this device; peer average 2.03/device2020-12: 0 reports for this device; peer average 1.8/device2021-01: 0 reports for this device; peer average 1.63/device2021-02: 0 reports for this device; peer average 1.69/device2021-03: 0 reports for this device; peer average 1.95/device2021-04: 0 reports for this device; peer average 1.45/device2021-05: 0 reports for this device; peer average 1.54/device2021-06: 0 reports for this device; peer average 2.98/device2021-07: 0 reports for this device; peer average 1.65/device2021-08: 0 reports for this device; peer average 2.12/device2021-09: 0 reports for this device; peer average 1.74/device2021-10: 0 reports for this device; peer average 2.05/device2021-11: 0 reports for this device; peer average 1.76/device2021-12: 0 reports for this device; peer average 2.23/device2022-01: 0 reports for this device; peer average 2.72/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 0 reports for this device; peer average 1.76/device2022-04: 0 reports for this device; peer average 1.69/device2022-05: 0 reports for this device; peer average 2.06/device2022-06: 0 reports for this device; peer average 1.74/device2022-07: 0 reports for this device; peer average 2.05/device2022-08: 0 reports for this device; peer average 1.79/device2022-09: 0 reports for this device; peer average 1.86/device2022-10: 0 reports for this device; peer average 1.72/device2022-11: 0 reports for this device; peer average 1.94/device2022-12: 0 reports for this device; peer average 1.64/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1.68/device2023-04: 0 reports for this device; peer average 1.71/device2023-05: 0 reports for this device; peer average 1.94/device2023-06: 0 reports for this device; peer average 1.64/device2023-07: 0 reports for this device; peer average 1.96/device2023-08: 0 reports for this device; peer average 2.52/device2023-09: 0 reports for this device; peer average 1.83/device2023-10: 0 reports for this device; peer average 1.81/device2023-11: 0 reports for this device; peer average 9.3/device2023-12: 0 reports for this device; peer average 3.69/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 0 reports for this device; peer average 2.09/device2024-03: 0 reports for this device; peer average 1.86/device2024-04: 0 reports for this device; peer average 1.38/device2024-05: 0 reports for this device; peer average 1.55/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1.91/device2024-08: 0 reports for this device; peer average 2.22/device2024-09: 0 reports for this device; peer average 1.89/device2024-10: 0 reports for this device; peer average 2.04/device2024-11: 0 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.81/device2025-02: 0 reports for this device; peer average 1.68/device2025-03: 0 reports for this device; peer average 1.63/device2025-04: 0 reports for this device; peer average 1.64/device2025-05: 0 reports for this device; peer average 1.57/device2025-06: 0 reports for this device; peer average 1.98/device2025-07: 0 reports for this device; peer average 1.89/device2025-08: 0 reports for this device; peer average 1.62/device2025-09: 0 reports for this device; peer average 1.57/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1.83/device2026-01: 0 reports for this device; peer average 1.84/device2026-02: 0 reports for this device; peer average 1.51/device2026-03: 0 reports for this device; peer average 2.61/device2026-04: 0 reports for this device; peer average 1.54/device2026-05: 0 reports for this device; peer average 1.6/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.19
2019-0301.64
2019-0401.42
2019-0501.59
2019-0601.51
2019-0701.69
2019-0802.18
2019-0901.31
2019-1002.23
2019-1101.56
2019-1201.34
2020-0101.63
2020-0201.74
2020-0301.46
2020-0401.45
2020-0501.62
2020-0601.74
2020-0701.77
2020-0801.54
2020-0902.47
2020-1001.94
2020-1102.03
2020-1201.8
2021-0101.63
2021-0201.69
2021-0301.95
2021-0401.45
2021-0501.54
2021-0602.98
2021-0701.65
2021-0802.12
2021-0901.74
2021-1002.05
2021-1101.76
2021-1202.23
2022-0102.72
2022-0202.35
2022-0301.76
2022-0401.69
2022-0502.06
2022-0601.74
2022-0702.05
2022-0801.79
2022-0901.86
2022-1001.72
2022-1101.94
2022-1201.64
2023-0102.44
2023-0202
2023-0301.68
2023-0401.71
2023-0501.94
2023-0601.64
2023-0701.96
2023-0802.52
2023-0901.83
2023-1001.81
2023-1109.3
2023-1203.69
2024-0101.9
2024-0202.09
2024-0301.86
2024-0401.38
2024-0501.55
2024-0601.75
2024-0701.91
2024-0802.22
2024-0901.89
2024-1002.04
2024-1101.73
2024-1201.69
2025-0101.81
2025-0201.68
2025-0301.63
2025-0401.64
2025-0501.57
2025-0601.98
2025-0701.89
2025-0801.62
2025-0901.57
2025-1001.67
2025-1102
2025-1201.83
2026-0101.84
2026-0201.51
2026-0302.61
2026-0401.54
2026-0501.6
2026-0601.65
This device (reports/month)Average device in MAX, ODP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K142488 — cites (transitively): K082309 (d1), K082310 (d1), K082712 (d1), K102026 (d1), K103297 (d1), K112986 (d1), K080822 (d2) — cited as predicate by K161081, K162351, K171046, K173022, K173260, K181079, K192132, K201193, K210497, K223412

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