VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K081439
Device Name VITOSS BIOACTIVE FOAM PACK BONE GRAFT SUBSTITUTE
Applicant
ORTHOVITA, INC.
45 great valley pkwy.
malvern, 
PA 
19355

Applicant Contact david j mcilhenny
Correspondent
ORTHOVITA, INC.
45 great valley pkwy.
malvern, 
PA 
19355

Correspodent Contact david j mcilhenny
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 05/22/2008
Decision Date 06/17/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No