POLYGRAFT BONE GRAFT SUBSTITUTE


Device Classification Name

filler, bone void, calcium compound

510(k) Number K030288
Device Name POLYGRAFT BONE GRAFT SUBSTITUTE
Original Applicant
OSTEOBIOLOGICS, INC.
university business park
12500 network, suite 112
san antonio, 
TX 
78249 -3308

Original Contact gabriele g neiderauer
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 01/28/2003
Decision Date 07/17/2003
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