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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 K243751
Device Name Mako Total Hip Application 5.0
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 Received12/05/2024
Decision Date 03/05/2025
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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