DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS


Device Classification Name

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

510(k) Number K023453
Device Name DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Original Contact cheryl hastings
Regulation Number 888.3350
Classification Product Code
JDI  
Date Received 10/15/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No