THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM


Device Classification Name

mesh, surgical, metal

510(k) Number K023882
Device Name THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM
Original Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Original Contact robert poggie
Regulation Number 878.3300
Classification Product Code
EZX  
Date Received 11/21/2002
Decision Date 02/19/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No