OSSATURA BCP BONE VOID FILLER


Device Classification Name

filler, bone void, calcium compound

510(k) Number K030131
Device Name OSSATURA BCP BONE VOID FILLER
Original Applicant
ISOTIS NV
49 plain st.
north attleboro, 
MA 
02760

Original Contact mary mcnamara-cullinane
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 01/14/2003
Decision Date 05/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No