Fortilink® IBF System With TETRAfuse®3D Technology, Include The Following Designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System
Intervertebral Fusion Device With Bone Graft, Lumbar
Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.
The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. Dba Rti Surgical, Inc. with the FDA for Fortilink® Ibf System With Tetrafuse®3d Technology, Include The Following Designs: Fortilink®-ts Ibf System, Fortilink®-l I Bf System, Fortilink®-c Ibf System.
Pre-market Notification Details
| Device ID | K190498 |
| 510k 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 |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 11621 Research Circle Alachua, FL 32615 |
| Contact | Kristina Hall |
| Correspondent | Justin Eggleton Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-07-05 |
Trademark Results [Fortilink]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORTILINK 87101032 5287571 Live/Registered |
Pioneer Surgical Technology, Inc. 2016-07-12 |
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