Medical Device Manufacturer · US , Marquette , MI

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

15 submissions · 15 cleared · Since 2015
15
Total
15
Cleared
0
Denied

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — FDA 510(k) Submissions

Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) has submitted 15 FDA 510(k) premarket notifications since 2015, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Cerclage, Fixation, Intervertebral Fusion Device With Integrated Fixation, Cervical, Posterior Cervical Screw System, Intervertebral Fusion Device With Bone Graft, Lumbar, Thoracolumbosacral Pedicle Screw System . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
EVOS Cabling System
K201497 · JDQ Cerclage, Fixation · Orthopedic
Oct 2020 145d
Streamline Navigated Instruments
K200095 · OLO Orthopedic Stereotaxic... · Orthopedic
Jun 2020 162d
Tritium Sternal Cable Plate System
K193468 · JDQ Cerclage, Fixation · Orthopedic
Mar 2020 87d
Streamline TL Spinal Fixation System
K192800 · NKB Thoracolumbosacral... · Orthopedic
Jan 2020 106d
Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology
K192718 · MAX Intervertebral Fusion... · Orthopedic
Dec 2019 84d
Fortilink? IBF System with TETRAfuse?3D Technology, include the following designs: Fortilink?-TS IBF System, Fortilink?-L I BF System, Fortilink?-C IBF System
K190498 · MAX Intervertebral Fusion... · Orthopedic
Jul 2019 127d
CervAlign? Anterior Cervical Plate System
K183060 · KWQ Appliance, Fixation,... · Orthopedic
Jan 2019 76d
Streamline OCT Occipito-Cervico-Thoracic System
K172139 · NKG Posterior Cervical Screw... · Orthopedic
Aug 2017 32d
Unison-C Anterior Cervical Fixation System
K170830 · OVE Intervertebral Fusion... · Orthopedic
Jun 2017 100d
Tritium? Sternal Cable Plate System
K161876 · JDQ Cerclage, Fixation · Orthopedic
Sep 2016 63d
Streamline OCT Occipito-Cervico-Thoracic System
K161498 · NKG Posterior Cervical Screw... · Orthopedic
Aug 2016 82d
Release Laminoplasty Fixation System
K153735 · NQW Orthosis, Spine, Plate,... · Orthopedic
Jan 2016 24d
Unison-C Anterior Cervical Fixation System
K152793 · OVE Intervertebral Fusion... · Orthopedic
Jan 2016 113d
Tritium Sternal Cable Plate System
K150581 · JDQ Cerclage, Fixation · Orthopedic
Jun 2015 87d
Streamline OCT Occipito-Cervico-Thoracic System
K150254 · KWP Appliance, Fixation,... · Orthopedic
Apr 2015 84d
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