CORTOSS BONE AUGMENTATION MATERIAL


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K080108
Device Name CORTOSS BONE AUGMENTATION MATERIAL
Applicant
ORTHOVITA, INC.
45 great valley pkwy.
malvern, 
PA 
19355

Applicant Contact gina m nagvajara
Correspondent
ORTHOVITA, INC.
45 great valley pkwy.
malvern, 
PA 
19355

Correspodent Contact gina m nagvajara
Regulation Number 888.3027
Classification Product Code
NDN  
Date Received 01/15/2008
Decision Date 06/05/2009
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Clinical Trials NCT00290862
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls