K251863
- 510(k) number
- K251863
- Device name
- CustomSurg OrthoPlanner
- Applicant
- Customsurg AG CH
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-07-07
- Date received
- 2025-06-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Radiology
510(k) Summary (official FDA PDF): K251863.pdf
Official FDA record: K251863
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.