NEXFLEX TOTAL HIP SYSTEM


Device Classification Name

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

510(k) Number K033580
Device Name NEXFLEX TOTAL HIP SYSTEM
Applicant
NEXMED, INC.
6110 corte del cedro
carlsbad, 
CA 
92009

Applicant Contact ellen a yarnall
Correspondent
NEXMED, INC.
6110 corte del cedro
carlsbad, 
CA 
92009

Correspodent Contact ellen a yarnall
Regulation Number 888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWY  
Date Received 11/13/2003
Decision Date 08/05/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No