Regulatory filing

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).

fda 510k · cleared · decided 2019-06-01

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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

Covered models (1)

ROSA

Sources (1)

https://www.zimmerbiomet.com/

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Identity

72032331-aa9d-43ac-b137-e8c36ee7251e