ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K080736
Device Name ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE
Applicant
APATECH LTD.
15058 armel drive
oregon city, 
OR 
97045

Applicant Contact candace f cederman
Correspondent
APATECH LTD.
15058 armel drive
oregon city, 
OR 
97045

Correspodent Contact candace f cederman
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 03/17/2008
Decision Date 04/16/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No