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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 K260222
Device Name Mako Total Knee Application
Applicant
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Applicant Contact Rita Koremblum
Correspondent
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Correspondent Contact Rita Koremblum
Regulation Number882.4560
Classification Product Code
OLO  
Date Received01/26/2026
Decision Date 02/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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