PALACOS R BONE CEMENT WITH GENTAMICIN


Device Classification Name

bone cement

510(k) Number K030086
Device Name PALACOS R BONE CEMENT WITH GENTAMICIN
Original Applicant
BIOMET, INC.
56 bell dr.
po box 587
warsaw, 
IN 
46581 -0587

Original Contact lonnie witham
Regulation Number 888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received 01/09/2003
Decision Date 12/17/2003
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

Yes