Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · Class II · Cleared Jul 5, 2019
| 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. |
| Product code | MAX |
| Device class | Class II |
| Decision date | Jul 5, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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