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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 patellofemorotibial, partial, semi-constrained, cemented, polymer/metal/polymer
510(k) Number K090763
Device Name RESTORIS MULTICOMPARTMENTAL KNEE (MCK) 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 Number888.3560
Classification Product Code
NPJ  
Subsequent Product Codes
HRY   HSX   KRR  
Date Received03/23/2009
Decision Date 06/17/2009
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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