RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K112507
Device Name RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
Applicant
MAKO SURGICAL CORPORATION
2555 davie road
fort lauderdale, 
FL 
33317

Applicant Contact dionne sanders
Correspondent
MAKO SURGICAL CORPORATION
2555 davie road
fort lauderdale, 
FL 
33317

Correspodent Contact dionne sanders
Regulation Number 882.4560
Classification Product Code
OLO  
Date Received 08/30/2011
Decision Date 03/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls