OPTETRAK B-SERIES TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K010434
Device Name OPTETRAK B-SERIES TOTAL KNEE SYSTEM
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Original Contact lisa simpson
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 02/13/2001
Decision Date 03/13/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls