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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 K150847
Device Name Foundation Interbody Devices
Applicant
Corelink, LLC
7606 Forsyth Blvd.
St.Louis,  MO  63105
Applicant Contact Sharon Gregory
Correspondent
The OrthoMedix Group, Inc.
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. Webb
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received03/31/2015
Decision Date 08/13/2015
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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