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Regulatory filing

K182964 (us_fda)

FDA 510(k) clearance for the Zimmer Biomet ROSA Knee System; reported 2019.

fda 510k · cleared · decided 2019-01-24


Machine-readable surfaces

Key facts

Jurisdiction
us_fda
Filing type
fda 510k
Status
cleared
Filing number
K182964
Filing date
2018-10-25
Decision date
2019-01-24
Verification posture
reported
Cap-flag notes
Filing number not yet captured. Upgrade to verified when the K-number is confirmed.

Applicant

Zimmer Biomet

Covered models (1)

Sources (1)

  1. https://www.zimmerbiomet.com

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Identity

b4a42d54-d472-41a5-991f-9a37c6e6e291