# DEN230078 (us_fda)

FDA De Novo authorization for the CMR Surgical Versius system (initial US indication); reported 2024.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: granted
- Filing number: DEN230078
- Filing date: 2023-11-21
- Decision date: 2024-10-11
- Verification posture: reported
- Cap-flag notes: Filing number not yet captured; De Novo pathway reported. Upgrade to verified when the DEN-number is confirmed.

## Applicant

- [CMR Surgical](/companies/cmr-surgical.md)

## Covered models (1)

- [Versius](/models/cmr-versius.md)

## Sources (1)

- [https://cmrsurgical.com](https://cmrsurgical.com)

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