# fda_510k (us_fda)

FDA 510(k) for ROSA Knee (2019), Hip (2021), ONE Brain (Feb 2019), Shoulder (2024). ROSA-Brain recall (2021, Class I).

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Filing date: 2019-01-01
- Decision date: 2019-06-01
- Verification posture: verified
- Cap-flag notes: Multiple clearances across indications. Class I recall.

## Applicant

- [Zimmer Biomet](/companies/zimmer-biomet.md)

## Covered models (1)

- [ROSA](/models/zimmer-biomet-rosa.md)

## Sources (1)

- [https://www.zimmerbiomet.com/](https://www.zimmerbiomet.com/)

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