EAUM TOTAL KNEE SYSTEM


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K110404
Device Name EAUM TOTAL KNEE SYSTEM
Applicant
CORENTEC CO., LTD
11234 el camino real
suite 200
san diego, 
CA 
92130

Applicant Contact kevin a thomas
Correspondent
CORENTEC CO., LTD
11234 el camino real
suite 200
san diego, 
CA 
92130

Correspodent Contact kevin a thomas
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 02/14/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No