Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine— 510(k) K223553
Substantially EquivalentBrainlab 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. Device class: 2.
Clearance details
- Applicant
- Brainlab AG
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Recent devices under product code OLO
view allMore clearances from Brainlab AG
view allAdverse 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, through . 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.