THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ

Device Classification Name

prosthesis, hip, cement restrictor

510(k) Number K033384
Device Name THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ
Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Applicant Contact marci halevi
Correspondent
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Correspodent Contact marci halevi
Regulation Number 878.3300
Classification Product Code
JDK  
Date Received 10/23/2003
Decision Date 11/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No