OSSIFUSE BONE SUBSTITUTE MATERIAL


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072355
Device Name OSSIFUSE BONE SUBSTITUTE MATERIAL
Applicant
ETEX CORP.
38 sidney st., 3rd flr
cambridge, 
MA 
02139

Applicant Contact pamela w adams
Correspondent
ETEX CORP.
38 sidney st., 3rd flr
cambridge, 
MA 
02139

Correspodent Contact pamela w adams
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/22/2007
Decision Date 09/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No