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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 K051196
Device Name TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1
Applicant
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Applicant Contact MARCI HALEVI
Correspondent
Implex Corp.
80 Commerce Dr.
Allendale,  NJ  07401
Correspondent Contact MARCI HALEVI
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/10/2005
Decision Date 06/17/2005
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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