Spira-V Open Matrix Corpectomy Cage
Model SPV-12145-3523 · CAMBER SPINE TECHNOLOGIES, LLC · DI B030SPV1214535230
MQP — Spinal Vertebral Body Replacement Device · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 1.38 |
| 2019-03 | 0 | 2.14 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.57 |
| 2019-06 | 0 | 2.14 |
| 2019-07 | 0 | 1.36 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1.4 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1.64 |
| 2020-01 | 0 | 1.57 |
| 2020-02 | 0 | 1.2 |
| 2020-03 | 0 | 1.43 |
| 2020-04 | 0 | 1.25 |
| 2020-05 | 0 | 1.2 |
| 2020-06 | 0 | 1.33 |
| 2020-07 | 0 | 2.5 |
| 2020-08 | 0 | 1.45 |
| 2020-09 | 0 | 1.62 |
| 2020-10 | 0 | 1.67 |
| 2020-11 | 0 | 1.13 |
| 2020-12 | 0 | 1.5 |
| 2021-01 | 0 | 1.31 |
| 2021-02 | 0 | 1.33 |
| 2021-03 | 0 | 1.78 |
| 2021-04 | 0 | 1.47 |
| 2021-05 | 0 | 1.29 |
| 2021-06 | 0 | 2.69 |
| 2021-07 | 0 | 1.58 |
| 2021-08 | 0 | 1.64 |
| 2021-09 | 0 | 1.38 |
| 2021-10 | 0 | 1.67 |
| 2021-11 | 0 | 1.44 |
| 2021-12 | 0 | 1.45 |
| 2022-01 | 0 | 1.38 |
| 2022-02 | 0 | 1.59 |
| 2022-03 | 0 | 1.67 |
| 2022-04 | 0 | 1.64 |
| 2022-05 | 0 | 1.79 |
| 2022-06 | 0 | 1.64 |
| 2022-07 | 0 | 1.44 |
| 2022-08 | 0 | 1.4 |
| 2022-09 | 0 | 2.29 |
| 2022-10 | 0 | 1.5 |
| 2022-11 | 0 | 1.8 |
| 2022-12 | 0 | 1.33 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1.44 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 1.17 |
| 2023-05 | 0 | 1.31 |
| 2023-06 | 0 | 1.25 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 0 | 1.63 |
| 2023-10 | 0 | 1.67 |
| 2023-11 | 0 | 1.22 |
| 2023-12 | 0 | 1.37 |
| 2024-01 | 0 | 1.8 |
| 2024-02 | 0 | 1.75 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 1.56 |
| 2024-05 | 0 | 2.25 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 1.62 |
| 2024-08 | 0 | 1.07 |
| 2024-09 | 0 | 1.55 |
| 2024-10 | 0 | 1.29 |
| 2024-11 | 0 | 1.38 |
| 2024-12 | 0 | 1.47 |
| 2025-01 | 0 | 1.38 |
| 2025-02 | 0 | 1.75 |
| 2025-03 | 0 | 3.63 |
| 2025-04 | 0 | 1.67 |
| 2025-05 | 0 | 2.2 |
| 2025-06 | 0 | 1.54 |
| 2025-07 | 0 | 1.45 |
| 2025-08 | 0 | 1.71 |
| 2025-09 | 0 | 1.56 |
| 2025-10 | 0 | 1.56 |
| 2025-11 | 0 | 1.53 |
| 2025-12 | 0 | 1.57 |
| 2026-01 | 0 | 1.4 |
| 2026-02 | 0 | 1.18 |
| 2026-03 | 0 | 1.9 |
| 2026-04 | 0 | 1.8 |
| 2026-05 | 0 | 1.67 |
| 2026-06 | 0 | 1.75 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K173800 — cites (transitively): K010530 (d1), K012254 (d1), K143490 (d1), K172446 (d1), K841189 (d1), K121741 (d2), K133529 (d2), K142112 (d2), K162986 (d2), P980048 (d3), K073351 (d3), K120345 (d3), K112316 (d3), K080588 (d3), K080699 (d3), K083894 (d3), K090782 (d3), K132790 (d3), K143297 (d3), P950002 (d4), P960025 (d4), K083626 (d4), K042571 (d4), K050624 (d4), K061836 (d4), K062132 (d4), K082014 (d4), K031672 (d4), K073202 (d4), K033517 (d4), K070754 (d4), K111983 (d4), K113561 (d4), K120203 (d4), K133184 (d4), K133784 (d4), K070382 (d5), K082848 (d5), K092336 (d5), K052950 (d5), K082235 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — CAMBER SPINE TECHNOLOGIES, LLC
Nothing in the loaded window.