HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1


Device Classification Name

spinal vertebral body replacement device

510(k) Number K022563
Device Name HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1
Original Applicant
IMPLEX CORP.
80 commerce dr.
allendale, 
NJ 
07401 -1600

Original Contact marci halevi
Regulation Number 888.3060
Classification Product Code
MQP  
Date Received 08/02/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No