Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Mixed Reality Spine Navigation

Model 1.1 · Brainlab SE · DI 04056481146672

SBF — Orthopedic Augmented Reality · Class II · 21 CFR 882.4560

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.

12342020-08: 0 reports for this device; peer average 3/device2021-09: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 4/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 1.5/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device0809120107081112010405070809101201020403080903
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0803
2021-0901
2021-1202
2022-0102
2022-0701
2022-0801
2022-1102
2022-1202
2023-0102
2023-0402
2023-0502
2023-0702
2023-0804
2023-0902
2023-1001.5
2023-1204
2024-0101
2024-0201
2024-0401
2025-0301
2025-0802
2025-0901
2026-0301
This device (reports/month)Average device in SBF (reports/device/month)

Regulatory clearances

  • K242569 SESE 2025-05-16 (k number procode)

Predicate lineage

K242569 — cites (transitively): K221618 (d1), K223290 (d1), K110204 (d2), K202320 (d2), K212245 (d2), K192890 (d2), K213264 (d2), K042721 (d3), K062358 (d3), K083483 (d3), K130594 (d3), K173274 (d3), K183605 (d3), K170011 (d3), K191660 (d3), K200484 (d3), K050438 (d4), K153660 (d4), K171356 (d4), K083310 (d4), K173977 (d4), K173978 (d4), K180238 (d4), K150216 (d5), K992927 (d5), K142107 (d5), K133916 (d5), K170600 (d5), K130721 (d6), K052632 (d6), K123023 (d6), K112387 (d7)

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