Pioneer Surgical Technology, Inc.

FDA Device Registration & Listing · Marquette, MI, US · Registration 1833824

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1833824
FEI Number
1000115331
Entity Name
Pioneer Surgical Technology, Inc.
City/State/Country
Marquette, MI, US
Establishment Address
375 RIVER PARK CIRCLE, Marquette, MI 49855, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Pioneer Surgical Technology, Inc. (Owner Number: 10084252)
Owner / Operator Contact Address
375 River Park Circle, Marquette, MI 49855, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201497
PMA Number
N/A

All Registered Proprietary Names

Streamline TL Spinal Fixation System Streamline® MIS Spinal Fixation System Streamline Occipito-Cervico-Thoracic (OCT) System Zimmer®* Cannulated Screw System Streamline® MIS Spinal Fixation System Streamline OCT Occipito-Cervico-Thoracic System CODA™ Anterior Cervical Plate System Streamline TL Spinal Fixation System CervAlign Anterior Cervical Plate System Songer® Spinal Cable System Streamline® MIS Spinal Fixation System Streamline TL Spinal Fixation System CODA™ Anterior Cervical Plate System EVOS Cabling System Streamline OCT Occipito-Cervico-Thoracic System CervAlign Anterior Cervical Plate System Spine Cable System Palisade Screw Tyber Medical Anatomical Plating System Geminus Volar Distal Radius Plating System Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System Cable-Ready® Cable Grip System Instruments Streamline® MIS Spinal Fixation System Fortilink-C Fortilink-TS IBF System Zimmer®* Cannulated Screw System Streamline® MIS Spinal Fixation System Streamline TL Spinal Fixation System Cable-Ready® Cable Grip System Instruments CervAlign Anterior Cervical Plate System CODA™ Anterior Cervical Plate System Spine Cable System Orthopaedic Cable System EVOS Cabling System Streamline TL Spinal Fixation System SternaLock® XP Rigid Fixation System Streamline TL Spinal Fixation System CODA™ Anterior Cervical Plate System TriALTIS™ Spine System Cable-Ready® Cable Grip System Instruments Streamline TL Spinal Fixation System Cable-Ready Cable Grip System: Cable-Ready Bone Plate System Streamline OCT Occipito-Cervico-Thoracic System Zimmer®* Cannulated Screw System Streamline TL Spinal Fixation System Streamline® MIS Spinal Fixation System CervAlign Anterior Cervical Plate System CODA™ Anterior Cervical Plate System Streamline TL Spinal Fixation System Zimmer®* Cannulated Screw System Streamline TL Spinal Fixation System Streamline OCT Occipito-Cervico-Thoracic System Sternal Cable System CODA™ Anterior Cervical Plate System CervAlign Anterior Cervical Plate System Zimmer®* Cannulated Screw System Streamline® MIS Spinal Fixation System CODA™ Anterior Cervical Plate System CervAlign Anterior Cervical Plate System Streamline® MIS Spinal Fixation System Fortilink-A IBF System Fortilink-TS IBF System Fortilink-C IBF System CODA™ Anterior Cervical Plate System CervAlign Anterior Cervical Plate System OSSE-LIGN Streamline OCT Occipito-Cervico-Thoracic System Streamline TL Spinal Fixation System CervAlign Anterior Cervical Plate System CODA™ Anterior Cervical Plate System Streamline Navigated Instruments EVOS Cabling System Cable-Ready® Cable Grip System Instruments Orthopaedic Cable System Streamline Occipito-Cervico-Thoracic (OCT) System Orthopaedic Cable System Zimmer®* Cannulated Screw System Streamline® MIS Spinal Fixation System Sternal Cable System Streamline TL Spinal Fixation System TiPlus EVOS Cabling System Fortilink-TC IBF System Fortilink-TS IBF System Streamline TL Spinal Fixation System Fortilink-A IBF System CODA™ Anterior Cervical Plate System Fortilink-C IBF System Trochanteric Reattachment Device System (TRD) CervAlign Anterior Cervical Plate System EVOS Cabling System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-02-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-02-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-31
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-31
HWX Tap, Bone Orthopedic Class 1 888.4540 2022-02-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-06-19
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-04-22
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-02-01
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-05-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-03-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-12-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-12-11
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-03-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-03-18
HWQ Passer Orthopedic Class 1 888.4540 2022-03-18
GAD Retractor General, Plastic Surgery Class 1 878.4800 2022-02-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-02-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-02-14
HXX Screwdriver Orthopedic Class 1 888.4540 2022-02-10
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2022-02-01
HTD Forceps General, Plastic Surgery Class 1 878.4800 2022-02-18
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-02-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-02-01
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2022-02-01
HXC Wrench Orthopedic Class 1 888.4540 2022-02-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-07
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2022-02-11
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-03-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-03-18
HWJ Awl Orthopedic Class 1 888.4540 2022-02-14
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2022-02-16
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2022-02-10
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-02-11
KTZ Caliper Orthopedic Class 1 888.4150 2022-02-17
HXG Tamp Orthopedic Class 1 888.4540 2022-02-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-21
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2022-02-10
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-04-22
HXW Bender Orthopedic Class 1 888.4540 2022-02-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-31
HXN Applier, Cerclage Orthopedic Class 1 888.4540 2022-02-01
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-31
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-02-01
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2022-02-14
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2025-04-03
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2022-02-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-12
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-12-12
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2022-02-01
HWT Template Orthopedic Class 1 888.4800 2022-02-10
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-04-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-31
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-01-31

Official Correspondent

Lisa Boyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pioneer Surgical Technology, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K140696 Pioneer Surgical Technology, Inc. STREAMLINE TL SPINAL FIXATION SYSTEM 2014-04-10
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05
K252461 Spinal Resources, Inc. Swedge™ Pedicle Screw Fixation System Bezier Rod 2026-01-13
K141398 Medicrea International SA PASS LP SPINAL SYSTEM 2015-01-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1833824. Last updated year: 2026. Please use registration number 1833824 when referencing this establishment in official correspondence.
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