NAVITRACK SYSTEM – OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE


Device Classification Name

orthopedic stereotaxic instrument

510(k) Number K110054
Device Name NAVITRACK SYSTEM – OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCE
Applicant
ZIMMER CAS
75 queen street
suite 3300
montreal, quebec, 

CA

h3c 2n6

Applicant Contact christopher mclean
Correspondent
ZIMMER CAS
75 queen street
suite 3300
montreal, quebec, 

CA

h3c 2n6

Correspodent Contact christopher mclean
Regulation Number 882.4560
Classification Product Code
OLO  
Date Received 01/07/2011
Decision Date 03/24/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No