MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS


Device Classification Name

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

510(k) Number K030055
Device Name MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC 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 01/06/2003
Decision Date 08/11/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls