Alignment Depth Control Spine
Model 56350 · Brainlab SE · DI 04056481141301
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-06 · 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 | 2.67 |
| 2019-02 | 0 | 3.61 |
| 2019-03 | 0 | 3.19 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 3.1 |
| 2019-06 | 0 | 2.72 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 2.93 |
| 2019-09 | 0 | 2.89 |
| 2019-10 | 0 | 3.84 |
| 2019-11 | 0 | 5.54 |
| 2019-12 | 0 | 3.54 |
| 2020-01 | 0 | 3.39 |
| 2020-02 | 0 | 4.56 |
| 2020-03 | 0 | 4.41 |
| 2020-04 | 0 | 7.69 |
| 2020-05 | 0 | 2.37 |
| 2020-06 | 0 | 3.54 |
| 2020-07 | 0 | 3.94 |
| 2020-08 | 0 | 2.61 |
| 2020-09 | 0 | 3.93 |
| 2020-10 | 0 | 5.63 |
| 2020-11 | 0 | 5.77 |
| 2020-12 | 0 | 4.33 |
| 2021-01 | 0 | 4.68 |
| 2021-02 | 0 | 4.08 |
| 2021-03 | 0 | 3.82 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 0 | 4.15 |
| 2021-06 | 0 | 3.79 |
| 2021-07 | 0 | 3.25 |
| 2021-08 | 0 | 2.96 |
| 2021-09 | 0 | 2.92 |
| 2021-10 | 0 | 2.27 |
| 2021-11 | 0 | 4.24 |
| 2021-12 | 0 | 2.72 |
| 2022-01 | 0 | 2.54 |
| 2022-02 | 0 | 3.16 |
| 2022-03 | 0 | 3.32 |
| 2022-04 | 0 | 2.45 |
| 2022-05 | 0 | 3.91 |
| 2022-06 | 0 | 4.21 |
| 2022-07 | 0 | 3.33 |
| 2022-08 | 0 | 2.9 |
| 2022-09 | 0 | 2.32 |
| 2022-10 | 0 | 3.76 |
| 2022-11 | 0 | 3.44 |
| 2022-12 | 0 | 4.22 |
| 2023-01 | 0 | 3.18 |
| 2023-02 | 0 | 3.44 |
| 2023-03 | 0 | 3.77 |
| 2023-04 | 0 | 3.26 |
| 2023-05 | 0 | 3.02 |
| 2023-06 | 0 | 2.6 |
| 2023-07 | 0 | 2.69 |
| 2023-08 | 0 | 2.51 |
| 2023-09 | 0 | 4.04 |
| 2023-10 | 0 | 3.21 |
| 2023-11 | 0 | 9.13 |
| 2023-12 | 0 | 4 |
| 2024-01 | 0 | 3.71 |
| 2024-02 | 0 | 4.15 |
| 2024-03 | 0 | 4.4 |
| 2024-04 | 0 | 3.95 |
| 2024-05 | 0 | 4.89 |
| 2024-06 | 0 | 4.54 |
| 2024-07 | 0 | 3.92 |
| 2024-08 | 0 | 4.59 |
| 2024-09 | 0 | 4.53 |
| 2024-10 | 0 | 6.31 |
| 2024-11 | 0 | 4.74 |
| 2024-12 | 0 | 4.01 |
| 2025-01 | 0 | 8.37 |
| 2025-02 | 0 | 4.23 |
| 2025-03 | 0 | 3.59 |
| 2025-04 | 0 | 4.2 |
| 2025-05 | 0 | 4.57 |
| 2025-06 | 0 | 4.14 |
| 2025-07 | 0 | 4.32 |
| 2025-08 | 0 | 5.03 |
| 2025-09 | 0 | 3.85 |
| 2025-10 | 0 | 3.97 |
| 2025-11 | 0 | 4.12 |
| 2025-12 | 0 | 4.59 |
| 2026-01 | 0 | 4.53 |
| 2026-02 | 0 | 4.25 |
| 2026-03 | 0 | 4.08 |
| 2026-04 | 0 | 3.9 |
| 2026-05 | 0 | 4.99 |
| 2026-06 | 0 | 3.99 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K202320 — cites (transitively): K183605 (d1), K083310 (d2) — cited as predicate by K202310, K210989, K221618, K222966, K252755
K252562 — cites (transitively): K221618 (d1), K110204 (d2), K202320 (d2), K212245 (d2), K042721 (d3), K062358 (d3), K083483 (d3), K183605 (d3), K170011 (d3), K050438 (d4), K153660 (d4), K083310 (d4), K150216 (d5), K992927 (d5)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Brainlab SE
- NAI 2025-02-20 Brainlab SE · 0 citations
- NAI 2025-02-20 Brainlab SE · 0 citations
- NAI 2016-02-25 Brainlab SE · 0 citations
- NAI 2016-02-25 Brainlab SE · 0 citations
- VAI 2013-06-21 Brainlab SE · 3 citations
- VAI 2013-06-21 Brainlab SE · 3 citations
- NAI 2011-05-27 Brainlab SE · 0 citations
- NAI 2011-05-27 Brainlab SE · 0 citations