Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.)
Marquette, MI, US
Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) appears in FDA device records in Marquette, MI. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 16
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 16 510(k) clearances for Pioneer Surgical Technology, Inc. (dba Rti Surgical, Inc.) between 2015 and 2020. The busiest year on record is 2020, with 5. The most recent is 2020, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 2 |
| 2019 | 3 |
| 2020 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K201497 | EVOS Cabling System | JDQ | Substantially Equivalent | |
| K200513 | DAC Dynamic Active Compression Plate | HRS | Substantially Equivalent | |
| K200095 | Streamline Navigated Instruments | OLO | Substantially Equivalent | |
| K193468 | Tritium Sternal Cable Plate System | JDQ | Substantially Equivalent | |
| K192800 | Streamline TL Spinal Fixation System | NKB | Substantially Equivalent | |
| K192718 | Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology | MAX | Substantially Equivalent | |
| K190498 | Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System | MAX | Substantially Equivalent | |
| K183060 | CervAlign™ Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K172139 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | Substantially Equivalent | |
| K170830 | Unison-C Anterior Cervical Fixation System | OVE | Substantially Equivalent | |
| K161876 | Tritium® Sternal Cable Plate System | JDQ | Substantially Equivalent | |
| K161498 | Streamline OCT Occipito-Cervico-Thoracic System | NKG | Substantially Equivalent | |
| K153735 | Release Laminoplasty Fixation System | NQW | Substantially Equivalent | |
| K152793 | Unison-C Anterior Cervical Fixation System | OVE | Substantially Equivalent | |
| K150581 | Tritium Sternal Cable Plate System | JDQ | Substantially Equivalent | |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | KWP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- JDQCerclage, Fixation
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OLOOrthopedic Stereotaxic Instrument
- NQWOrthosis, Spine, Plate, Laminoplasty, Metal
- HRSPlate, Fixation, Bone
- NKGPosterior Cervical Screw System
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain