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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(k) Number K082172
Device Name MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM
Applicant
Mako Surgical Corporation
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Applicant Contact WILLIAM F TAPIA
Correspondent
Mako Surgical Corporation
2555 Davie Rd.
Fort Lauderdale,  FL  33317
Correspondent Contact WILLIAM F TAPIA
Regulation Number888.3520
Classification Product Code
HSX  
Subsequent Product Codes
HRY   KRR   NPJ  
Date Received08/01/2008
Decision Date 11/28/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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