HA PMI FEMORAL HIP STEM


Device Classification Name

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

510(k) Number K030048
Device Name HA PMI FEMORAL HIP STEM
Original Applicant
BIOMET ORTHOPEDICS, INC.
56 east bell dr.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact patricia beres
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Code
MEH  
Date Received 01/06/2003
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No