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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, Lumbar
510(k) Number K190498
Device Name Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
Applicant
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
11621 Research Circle
Alachua,  FL  32615
Applicant Contact Kristina Hall
Correspondent
Musculoskeletal Clinical Regulatory Advisers, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Justin Eggleton
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received02/28/2019
Decision Date 07/05/2019
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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