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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 K170891
Device Name Mako Partial Knee Application
Applicant
MAKO Surgical Corp.
2555 Davie Rd
Fort Lauderdale,  FL  33317
Applicant Contact Shikha Khandelwal
Correspondent
MAKO Surgical Corp.
2555 Davie Rd
Fort Lauderdale,  FL  33317
Correspondent Contact Shikha Khandelwal
Regulation Number882.4560
Classification Product Code
OLO  
Date Received03/27/2017
Decision Date 05/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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