A-BSM BONE SUBSTITUTE MATERIAL


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072636
Device Name A-BSM BONE SUBSTITUTE MATERIAL
Applicant
ETEX CORP.
38 sidney st.
cambridge, 
MA 
02139

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

Correspodent Contact pamela w adams
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 09/18/2007
Decision Date 10/23/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No