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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 K010378
Device Name HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Applicant Contact JOHN SCHALAGO
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401 -1600
Correspondent Contact JOHN SCHALAGO
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/08/2001
Decision Date 01/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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