OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY


Device Classification Name

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

510(k) Number K023186
Device Name OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Original Contact martin sprunch
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 09/24/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No