FDA 510(k) Applications Submitted by Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K190498 02/28/2019 Fortilink« IBF System with TETRAfuse«3D Technology, include the following designs: Fortilink«-TS IBF System, Fortilink«-L I BF System, Fortilink«-C IBF System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
K200095 01/16/2020 Streamline Navigated Instruments Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
K170830 03/20/2017 Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
K161876 07/08/2016 Tritium« Sternal Cable Plate System Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact