MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II


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

Correspodent Contact william f tapia
Regulation Number 888.3520
Classification Product Code
HSX  
Date Received 02/12/2008
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