CALCIGEN PSI BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K030178
Device Name CALCIGEN PSI BONE GRAFT SUBSTITUTE
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact mary verstynen
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 01/17/2003
Decision Date 02/26/2003
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