CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL


Device Classification Name

bone cement

510(k) Number K021715
Device Name CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
Original Applicant
EXACTECH, INC.
2320 n.w. 66th ct.
gainesville, 
FL 
32653

Original Contact gary j miller
Regulation Number 888.3027
Classification Product Code
LOD  
Date Received 05/23/2002
Decision Date 06/12/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No