Please complete the following questionnaire. At the end, upload your DICOM data as a ZIP file.

1. Practice / Clinic

2. Contact person

3. PSI Case information

4. DICOM data

Please upload the DICOM data exclusively as a ZIP file.

5. Regulatory notice pursuant to MDR (EU) 2017/745

The product offered is manufactured as a patient-specific custom-made device in accordance with MDR (EU) 2017/745. Manufacture and execution are based exclusively on the patient-specific requirements specified by the treating physician.

Release for implantation is granted exclusively by the responsible physician after review of the provided planning and design documents. The product may only be used clinically after written or documented release.

Responsibility for the medical evaluation, indication and final suitability for implantation lies with the treating medical professionals.

Customer

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