REDUCED SIZE ONCOLOGY SALVAGE SYSTEM


Device Classification Name

prosthesis, knee, femorotibial, constrained, cemented, metal/polymer

510(k) Number K021260
Device Name REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
Original Applicant
BIOMET, INC.
56 east bell dr.
warsaw, 
IN 
46581 -0587

Original Contact sara b shultz
Regulation Number 888.3510
Classification Product Code
KRO  
Date Received 04/19/2002
Decision Date 06/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No