Regulatory filing

fda_510k (us_fda)

FDA 510(k) clearance for Monogram mBOS semi-autonomous orthopedic surgical robot.

fda 510k · cleared · decided 2025-03-17

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2025-03-17
Decision date: 2025-03-17
Verification posture: verified
Cap-flag notes: Semi-autonomous. Cap-flag.

Covered models (1)

mBos TKA System

Sources (1)

https://www.monogramorthopaedics.com/

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Identity

8c9e1018-b970-4840-a1ba-aa25ed49e5b9