OPTERTRAK LOGIC PSC TIBIAL INSERT


Device Classification Name

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

510(k) Number K110547
Device Name OPTERTRAK LOGIC PSC TIBIAL INSERT
Applicant
EXACTECH SARASOTA
2320 nw 66th court
gainesville, 
FL 
32653

Applicant Contact patrick hughes
Correspondent
EXACTECH SARASOTA
2320 nw 66th court
gainesville, 
FL 
32653

Correspodent Contact patrick hughes
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 02/25/2011
Decision Date 04/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No