VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072184
Device Name VITOSS BIOACTIVE FOAM BONE GRAFT SUBSTITUTE
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 888.3045
Classification Product Code
MQV  
Date Received 08/06/2007
Decision Date 09/18/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No