PRESS-FIT HEAD RESURFACING DEVICE


Device Classification Name

prosthesis, hip, femoral, resurfacing

510(k) Number K023188
Device Name PRESS-FIT HEAD RESURFACING 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 09/24/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No