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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 K220459
Device Name Mako Total Knee Application
Applicant
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Applicant Contact Emily DiMambro
Correspondent
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Correspondent Contact Emily DiMambro
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/17/2022
Decision Date 04/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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