BALANCE HIP SYSTEM


Device Classification Name

prosthesis, hip, semi-constrained (metal uncemented acetabular component)

510(k) Number K050251
Device Name BALANCE HIP SYSTEM
Applicant
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Applicant Contact gary baker
Correspondent
BIOMET, INC.
56 east bell dr.
box 587
warsaw, 
IN 
46581 -0587

Correspodent Contact gary baker
Regulation Number 888.3330
Classification Product Code
KWA  
Subsequent Product Codes
JDI   JDL   KWY   KWZ   LPH  
LZO   LZY   MEH  
Date Received 02/03/2005
Decision Date 05/27/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No