CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT

Device Classification Name

bone cement

510(k) Number K033596
Device Name CEMEX GENTA BONE CEMENT; CEMEX GENTA SYSTEM BONE CEMENT
Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Applicant Contact gary miller
Correspondent
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Correspodent Contact gary miller
Regulation Number 888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received 11/14/2003
Decision Date 05/10/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes