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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
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