RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM


Device Classification Name

prosthesis, hip, semi-constrained, metal/polymer, cemented

510(k) Number K023085
Device Name RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
Original Applicant
BIOMET ORTHOPEDICS, INC.
p.o. box 587
warsaw, 
IN 
46581 -0587

Original Contact dalene t binkley
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 09/17/2002
Decision Date 10/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No