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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 K250608
Device Name Mako Total Knee Application (3.0); Hybrid Tip Pointer
Applicant
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Applicant Contact Shikha Khandelwal
Correspondent
Mako Surgical Corp.
3365 Enterprise Ave.
Weston,  FL  33331
Correspondent Contact Shikha Khandelwal
Regulation Number882.4560
Classification Product Code
OLO  
Date Received02/28/2025
Decision Date 04/25/2025
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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