VSP System
Model Intermediate Sandwich Surgical Splint · 3D SYSTEMS, INC. · DI 00816847020558
DZJ — Driver, Wire, And Bone Drill, Manual · Class II · 21 CFR 872.4120
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
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) |
|---|---|---|
| 2019-01 | 0 | 4.67 |
| 2019-02 | 0 | 9.4 |
| 2019-03 | 0 | 7.11 |
| 2019-04 | 0 | 6.8 |
| 2019-05 | 0 | 11 |
| 2019-06 | 0 | 8.82 |
| 2019-07 | 0 | 10.67 |
| 2019-08 | 0 | 15.7 |
| 2019-09 | 0 | 8.56 |
| 2019-10 | 0 | 5.44 |
| 2019-11 | 0 | 6.78 |
| 2019-12 | 0 | 10.33 |
| 2020-01 | 0 | 4.11 |
| 2020-02 | 0 | 8.23 |
| 2020-03 | 0 | 8.27 |
| 2020-04 | 0 | 9.77 |
| 2020-05 | 0 | 5.38 |
| 2020-06 | 0 | 2.45 |
| 2020-07 | 0 | 3.25 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 2.6 |
| 2020-10 | 0 | 3.1 |
| 2020-11 | 0 | 2.31 |
| 2020-12 | 0 | 3.42 |
| 2021-01 | 0 | 2.69 |
| 2021-02 | 0 | 2.82 |
| 2021-03 | 0 | 3.46 |
| 2021-04 | 0 | 3.18 |
| 2021-05 | 0 | 3.67 |
| 2021-06 | 0 | 3.32 |
| 2021-07 | 0 | 4.38 |
| 2021-08 | 0 | 3.8 |
| 2021-09 | 0 | 2.2 |
| 2021-10 | 0 | 2.88 |
| 2021-11 | 0 | 2.87 |
| 2021-12 | 0 | 4.08 |
| 2022-01 | 0 | 5 |
| 2022-02 | 0 | 2.5 |
| 2022-03 | 0 | 3 |
| 2022-04 | 0 | 2 |
| 2022-05 | 0 | 1.58 |
| 2022-06 | 0 | 3.5 |
| 2022-07 | 0 | 2.93 |
| 2022-08 | 0 | 3.15 |
| 2022-09 | 0 | 5 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 1.94 |
| 2022-12 | 0 | 2.14 |
| 2023-01 | 0 | 2.27 |
| 2023-02 | 0 | 2.27 |
| 2023-03 | 0 | 2.39 |
| 2023-04 | 0 | 2.14 |
| 2023-05 | 0 | 1.58 |
| 2023-06 | 0 | 2.79 |
| 2023-07 | 0 | 2.56 |
| 2023-08 | 0 | 2.11 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 3.58 |
| 2023-11 | 0 | 2.1 |
| 2023-12 | 0 | 1.87 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2.76 |
| 2024-03 | 0 | 2.33 |
| 2024-04 | 0 | 4.53 |
| 2024-05 | 0 | 2.42 |
| 2024-06 | 0 | 2.44 |
| 2024-07 | 0 | 2.95 |
| 2024-08 | 0 | 3.22 |
| 2024-09 | 0 | 3.36 |
| 2024-10 | 0 | 3.09 |
| 2024-11 | 0 | 3.28 |
| 2024-12 | 0 | 2.28 |
| 2025-01 | 0 | 6.17 |
| 2025-02 | 0 | 6.5 |
| 2025-03 | 0 | 2.58 |
| 2025-04 | 0 | 2.36 |
| 2025-05 | 0 | 2.35 |
| 2025-06 | 0 | 2.8 |
| 2025-07 | 0 | 2.79 |
| 2025-08 | 0 | 3.78 |
| 2025-09 | 0 | 2.86 |
| 2025-10 | 0 | 9.4 |
| 2025-11 | 0 | 2.83 |
| 2025-12 | 0 | 6.03 |
| 2026-01 | 0 | 6.9 |
| 2026-02 | 0 | 3.84 |
| 2026-03 | 0 | 13.11 |
| 2026-04 | 0 | 11.4 |
| 2026-05 | 0 | 16.65 |
| 2026-06 | 0 | 9.38 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K120956 — cites (transitively): K060950 (d1), K073468 (d1), K970617 (d1) — cited as predicate by K132600, K143222, K181241, K181813, K192282, K212570, K231520, K242263
K133907 — cited as predicate by K143222, K151285, K192192, K193499, K212570
K192192 — cites (transitively): K133907 (d1) — cited as predicate by K193136, K193143, K210347, K220648, K261826
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — 3D SYSTEMS, INC.
- NAI 2023-09-15 Medical Modeling, a 3D Systems Company · 0 citations
- NAI 2021-06-15 Medical Modeling, a 3D Systems Company · 0 citations
- NAI 2017-05-05 Medical Modeling, a 3D Systems Company · 0 citations
- NAI 2015-06-03 3D Systems, Inc. · 0 citations
- NAI 2014-04-25 Medical Modeling, a 3D Systems Company · 0 citations