HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

510(k) Number K023409
Device Name HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS
Original Applicant
BIOMET, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia sandborn beres
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received 10/10/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No