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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 K092794
Device Name TRANSCORP ACIF SYSTEM
Applicant
TRANSCORP, INC.
1000 100TH ST. SW, SUITE F
BYRON CENTER,  MI 
Applicant Contact ANDREW RODENHOUSE
Correspondent
TRANSCORP, INC.
1000 100TH ST. SW, SUITE F
BYRON CENTER,  MI 
Correspondent Contact ANDREW RODENHOUSE
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/11/2009
Decision Date 09/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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