X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS


Device Classification Name

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

510(k) Number K030501
Device Name X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
Applicant
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Applicant Contact patricia sandborn beres
Correspondent
BIOMET, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact patricia sandborn beres
Regulation Number 888.3358
Classification Product Code
LPH  
Date Received 02/19/2003
Decision Date 03/20/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No