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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K121178
Device Name TRANSCORP ACIF SYSTEM
Applicant
Transcorp, Inc.
1000 100th St. SW, Suite F
Byron Center,  MI  49315
Applicant Contact ANDREW RODENHOUSE
Correspondent
Transcorp, Inc.
1000 100th St. SW, Suite F
Byron Center,  MI  49315
Correspondent Contact ANDREW RODENHOUSE
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/18/2012
Decision Date 07/05/2013
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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