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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K242121
Device Name mBôs (Monogram mBôs TKA System)
Applicant
Monogram Orthopaedics, Inc.
3913 Todd Lane
Suite 307
Austin,  TX  78744
Applicant Contact Patel Nisha
Correspondent
Monogram Orthopaedics, Inc.
3913 Todd Lane
Suite 307
Austin,  TX  78744
Correspondent Contact Nisha Patel
Regulation Number882.4560
Classification Product Code
OLO  
Date Received07/19/2024
Decision Date 03/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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