Company · US
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2020. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDQ | Cerclage, Fixation | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| NKG | Posterior Cervical Screw System | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| HRS | Plate, Fixation, Bone | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 28, 2020 | K201497 | EVOS Cabling System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Jul 22, 2020 | K200513 | DAC Dynamic Active Compression Plate Pioneer Surgical Technology, Inc., Dba Rti Surgical | HRS |
| Jun 26, 2020 | K200095 | Streamline Navigated Instruments Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OLO |
| Mar 12, 2020 | K193468 | Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Jan 14, 2020 | K192800 | Streamline TL Spinal Fixation System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKB |
| Dec 20, 2019 | K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX |
| Jul 5, 2019 | K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®- Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | MAX |
| Jan 17, 2019 | K183060 | CervAlign Anterior Cervical Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | KWQ |
| Aug 18, 2017 | K172139 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKG |
| Jun 28, 2017 | K170830 | Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OVE |
| Sep 9, 2016 | K161876 | Tritium® Sternal Cable Plate System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | JDQ |
| Aug 22, 2016 | K161498 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NKG |
| Jan 21, 2016 | K153735 | Release Laminoplasty Fixation System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | NQW |
| Jan 19, 2016 | K152793 | Unison-C Anterior Cervical Fixation System Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | OVE |
| Jun 4, 2015 | K150581 | Tritium Sternal Cable Plate System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | JDQ |
| Apr 28, 2015 | K150254 | Streamline OCT Occipito-Cervico-Thoracic System Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | KWP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||