MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM


Device Classification Name

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

510(k) Number K000335
Device Name MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM
Original Applicant
BIOMET, INC.
airport industrial park,
p.o.box 587
warsaw, 
IN 
46581 -0587

Original Contact fred mcclure
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received 02/03/2000
Decision Date 02/25/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No