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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 K080368
Device Name MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II
Applicant
Mako Surgical Corp.
2555 Davie Rd., Suite 110
Ft. Lauderdale,  FL  33317
Applicant Contact WILLIAM F TAPIA
Correspondent
Mako Surgical Corp.
2555 Davie Rd., Suite 110
Ft. Lauderdale,  FL  33317
Correspondent Contact WILLIAM F TAPIA
Regulation Number888.3520
Classification Product Code
HSX  
Date Received02/12/2008
Decision Date 06/20/2008
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
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