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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 K150521
Device Name Interbody Fusion (IBF)/Vertebral Body Replacement(VBR) System
Applicant
Rti Surgical, Inc. Dba Rti Biologics
11621 Research Cir.
Alachua,  FL  32615
Applicant Contact Jennifer Bonacci
Correspondent
Rti Surgical, Inc. Dba Rti Biologics
11621 Research Cir.
Alachua,  FL  32615
Correspondent Contact Jennifer Bonacci
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Codes
MAX   MQP  
Date Received03/02/2015
Decision Date 05/15/2015
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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