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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 K123388
Device Name K7C SPACER
Applicant
K7, LLC
P.O. Box 566
Chesterland,  OH  44026 -2141
Applicant Contact KARREN E WARDEN, PHD
Correspondent
K7, LLC
P.O. Box 566
Chesterland,  OH  44026 -2141
Correspondent Contact KARREN E WARDEN, PHD
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/02/2012
Decision Date 01/04/2013
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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