OPAL
Model SD08.803.116 · Synthes GmbH · DI 10705034705309
MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080
MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
| Initiated | Recall # | Class | Status | Reason | Link basis |
|---|---|---|---|---|---|
| 2016-02-18 | Z-1392-2016 | Class II | Terminated | The label on the outer packaging does not match the product inside and intended use of the device. | k number procode |
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 | 1.59 |
| 2019-02 | 0 | 1.26 |
| 2019-03 | 0 | 1.76 |
| 2019-04 | 0 | 1.41 |
| 2019-05 | 0 | 1.59 |
| 2019-06 | 0 | 1.67 |
| 2019-07 | 0 | 1.59 |
| 2019-08 | 0 | 1.4 |
| 2019-09 | 0 | 1.3 |
| 2019-10 | 0 | 1.77 |
| 2019-11 | 0 | 1.52 |
| 2019-12 | 0 | 1.44 |
| 2020-01 | 0 | 1.65 |
| 2020-02 | 0 | 1.63 |
| 2020-03 | 0 | 1.45 |
| 2020-04 | 0 | 1.39 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1.74 |
| 2020-07 | 0 | 2 |
| 2020-08 | 0 | 1.58 |
| 2020-09 | 0 | 2.26 |
| 2020-10 | 0 | 1.9 |
| 2020-11 | 0 | 1.76 |
| 2020-12 | 0 | 1.65 |
| 2021-01 | 0 | 1.56 |
| 2021-02 | 0 | 1.58 |
| 2021-03 | 0 | 1.92 |
| 2021-04 | 0 | 1.52 |
| 2021-05 | 0 | 1.48 |
| 2021-06 | 0 | 2.39 |
| 2021-07 | 0 | 1.68 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 1.66 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 1.77 |
| 2021-12 | 0 | 2.15 |
| 2022-01 | 0 | 2.59 |
| 2022-02 | 0 | 2.21 |
| 2022-03 | 0 | 1.74 |
| 2022-04 | 0 | 1.73 |
| 2022-05 | 0 | 2.04 |
| 2022-06 | 0 | 1.76 |
| 2022-07 | 0 | 1.96 |
| 2022-08 | 0 | 1.76 |
| 2022-09 | 0 | 1.88 |
| 2022-10 | 0 | 1.7 |
| 2022-11 | 0 | 1.91 |
| 2022-12 | 0 | 1.62 |
| 2023-01 | 0 | 2.39 |
| 2023-02 | 0 | 1.94 |
| 2023-03 | 0 | 1.95 |
| 2023-04 | 0 | 1.71 |
| 2023-05 | 0 | 1.79 |
| 2023-06 | 0 | 1.68 |
| 2023-07 | 0 | 2.03 |
| 2023-08 | 0 | 1.71 |
| 2023-09 | 0 | 1.89 |
| 2023-10 | 0 | 1.81 |
| 2023-11 | 0 | 8.19 |
| 2023-12 | 0 | 3.09 |
| 2024-01 | 0 | 1.85 |
| 2024-02 | 0 | 2.05 |
| 2024-03 | 0 | 1.92 |
| 2024-04 | 0 | 1.41 |
| 2024-05 | 0 | 1.7 |
| 2024-06 | 0 | 1.73 |
| 2024-07 | 0 | 1.84 |
| 2024-08 | 0 | 1.87 |
| 2024-09 | 0 | 1.83 |
| 2024-10 | 0 | 1.93 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 1.73 |
| 2025-02 | 0 | 1.68 |
| 2025-03 | 0 | 2.02 |
| 2025-04 | 0 | 1.61 |
| 2025-05 | 0 | 1.88 |
| 2025-06 | 0 | 1.91 |
| 2025-07 | 0 | 1.72 |
| 2025-08 | 0 | 1.63 |
| 2025-09 | 0 | 1.58 |
| 2025-10 | 0 | 1.68 |
| 2025-11 | 0 | 1.87 |
| 2025-12 | 0 | 1.78 |
| 2026-01 | 0 | 1.78 |
| 2026-02 | 0 | 1.47 |
| 2026-03 | 0 | 2.45 |
| 2026-04 | 0 | 1.65 |
| 2026-05 | 0 | 1.6 |
| 2026-06 | 0 | 1.63 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K072791 — cited as predicate by K092815, K100544, K110442, K110927, K111512, K120024, K122989, K123180, K123207, K130573, K131082, K131178, K131671, K140303, K141443, K153356, K163422, K170243, K170676, K171914, K181030, K181347, K211845, K220449, K242267
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Synthes GmbH
- Warning Letter 2012-02-16 Synthes, Inc.
- NAI 2017-08-08 Synthes GmbH · 0 citations
- NAI 2017-01-18 Synthes (USA), LLC · 0 citations
- VAI 2015-05-08 Synthes (USA), LLC · 2 citations
- VAI 2013-11-13 Synthes, Inc. · 1 citations
- NAI 2013-05-16 Synthes, Inc. · 0 citations
- VAI 2012-10-19 Synthes, Inc. · 1 citations
- NAI 2012-02-01 Synthes (USA), LLC · 0 citations
- OAI 2011-09-15 Synthes, Inc. · 10 citations