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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 K133039
Device Name RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
Applicant
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Applicant Contact JONATHAN REEVES
Correspondent
MAKO SURGICAL CORPORATION
2555 DAVIE ROAD
FORT LAUDERDALE,  FL  33317
Correspondent Contact JONATHAN REEVES
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Codes
HRY   HSX   KRR   OIY  
Date Received09/26/2013
Decision Date 12/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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