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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K021025
Device Name MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact ROBERT POGGIE
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact ROBERT POGGIE
Regulation Number888.3060
Classification Product Code
MQP  
Date Received03/29/2002
Decision Date 05/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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