CEMENTED FEMORAL HEAD RESURFING DEVICE


Device Classification Name

prosthesis, hip, femoral, resurfacing

510(k) Number K021799
Device Name CEMENTED FEMORAL HEAD RESURFING DEVICE
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia sandborn beres
Regulation Number 888.3400
Classification Product Code
KXA  
Date Received 05/31/2002
Decision Date 06/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No