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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 ROAD
FORT LAUDERDALE,  FL  33317
Applicant Contact WILLIAM F TAPIA
Correspondent
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
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
Recalls CDRH Recalls
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