CEMENT RESTRICTOR, SMALL AND LARGE


Device Classification Name

prosthesis, hip, cement restrictor

510(k) Number K021765
Device Name CEMENT RESTRICTOR, SMALL AND LARGE
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Original Contact gary miller
Regulation Number 878.3300
Classification Product Code
JDK  
Date Received 05/29/2002
Decision Date 08/16/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No