Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine— 510(k) K223553

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K223553 for Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine, Substantially Equivalent on 2023-08-02. Applicant: Brainlab AG.

Clearance details

Applicant: Brainlab AG
Product code: Code OLO
Advisory panel: Neurology
Date received: 2022-11-25
Decision date: 2023-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLO

product code OLO

Death: 11
Injury: 2,799
Malfunction: 11,105
Other: 1
Total: 13,916

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.