MODIFICATION TO SPACE CPSXL BONE CEMENT


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K072496
Device Name MODIFICATION TO SPACE CPSXL BONE CEMENT
Applicant
DFINE, INC.
3047 orchard pkwy.
san jose, 
CA 
95134

Applicant Contact robert poser
Correspondent
DFINE, INC.
3047 orchard pkwy.
san jose, 
CA 
95134

Correspodent Contact robert poser
Regulation Number 888.3027
Classification Product Code
NDN  
Date Received 09/05/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No