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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 K241011
Device Name Mako Total Knee Application
Applicant
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Applicant Contact Edwards Anne
Correspondent
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Correspondent Contact Anne Edwards
Regulation Number882.4560
Classification Product Code
OLO  
Date Received04/12/2024
Decision Date 06/11/2024
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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