Arena-C
Model 01-72007-09 · SPINEFRONTIER, INC. · DI 00190361023029
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 1.17 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 6.67 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 3.56 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.33 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 1.57 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1.33 |
| 2020-08 | 0 | 1.42 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1.58 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1.25 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 1.71 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 4.05 |
| 2021-07 | 0 | 1.25 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1.38 |
| 2022-01 | 0 | 1.25 |
| 2022-02 | 0 | 1.5 |
| 2022-03 | 0 | 1.64 |
| 2022-04 | 0 | 1.2 |
| 2022-05 | 0 | 1.85 |
| 2022-06 | 0 | 1.4 |
| 2022-07 | 0 | 1.29 |
| 2022-08 | 0 | 1.43 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 1.33 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1.57 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1.5 |
| 2023-06 | 0 | 1 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 5.78 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.6 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1.25 |
| 2024-01 | 0 | 4 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1.5 |
| 2024-04 | 0 | 1.5 |
| 2024-05 | 0 | 1.33 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 2 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 1.2 |
| 2024-11 | 0 | 1.6 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 0 | 1.43 |
| 2025-02 | 0 | 1.78 |
| 2025-03 | 0 | 1.4 |
| 2025-04 | 0 | 1.88 |
| 2025-05 | 0 | 1.25 |
| 2025-06 | 0 | 1.6 |
| 2025-07 | 0 | 2.4 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 0 | 1.5 |
| 2025-11 | 0 | 1.83 |
| 2025-12 | 0 | 1.67 |
| 2026-01 | 0 | 1.38 |
| 2026-02 | 0 | 1.38 |
| 2026-03 | 0 | 1.63 |
| 2026-04 | 0 | 1.38 |
| 2026-05 | 0 | 1.71 |
| 2026-06 | 0 | 1.89 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K142026 — cites (transitively): K090064 (d1), K110733 (d1), K113518 (d1), K073351 (d2), K082260 (d2), P980048 (d2) — cited as predicate by K142269, K151496, K152515, K153615, K161809, K172323, K172484, K173324, K180674
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SPINEFRONTIER, INC.
- Warning Letter 2012-08-08 SpineFrontier, Inc.
- VAI 2026-04-02 SpineFrontier, Inc. · 1 citations
- VAI 2019-01-29 SpineFrontier, Inc. · 0 citations
- NAI 2013-08-05 SpineFrontier, Inc. · 0 citations
- OAI 2012-07-11 SpineFrontier, Inc. · 9 citations