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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 K163673
Device Name Fortilink™-C with TETRAfuse™ 3D Technology
Applicant
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact Diana Taylor
Correspondent
Rti Surgical, Inc.
11621 Research Cir.
Alachua,  FL  32615
Correspondent Contact Diana Taylor
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MQP  
Date Received12/27/2016
Decision Date 05/23/2017
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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