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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 integrated fixation, cervical
510(k) Number K122008
Device Name INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Applicant
INCITE INNOVATION LLC
1500 MAIN STREET
STE. 2410
SPRINGFIELD,  MA  01115
Applicant Contact JOHN KIRWAN
Correspondent
INCITE INNOVATION LLC
1500 MAIN STREET
STE. 2410
SPRINGFIELD,  MA  01115
Correspondent Contact JOHN KIRWAN
Regulation Number888.3080
Classification Product Code
OVE  
Date Received07/09/2012
Decision Date 11/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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