FDA Registration
Active
🇺🇸 United States
Pioneer Surgical Technology, Inc.
Reg #: 1833824
·
FEI: 1000115331
·
Expires 2026
Products
43
Proprietary Names
37
Establishment Types
3
Classifications
43
Registration Details
- Registration Name
- Pioneer Surgical Technology, Inc.
- Registration Number
- 1833824
- FEI Number
- 1000115331
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 375 RIVER PARK CIRCLE
- City
- Marquette
- State
- MI
- ZIP
- 49855
- Country
- US
Regulatory Submissions
- 510(k) Number
- K941213
Owner / Operator
- Firm Name
- Pioneer Surgical Technology, Inc.
- Operator Number
- 10084252
- Address
- 375 River Park Circle
- City
- Marquette
- State
- MI
- Postal Code
- 49855
- Country
- US
- Correspondent
- Lisa Boyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-02-01 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-02-01 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2022-01-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2022-02-14 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2026-06-19 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2022-04-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2022-02-01 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2026-03-31 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2022-03-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-02-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-02-14 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2022-02-10 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2022-02-01 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2022-02-18 |
| Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | GAQ | Class 2 | General, Plastic Surgery | No | 2022-02-01 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2022-02-16 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-12-07 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2022-02-11 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2022-02-14 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2022-02-16 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2022-02-10 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2022-02-11 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2022-02-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2022-02-11 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2022-02-10 |
| Bender | HXW | Class 1 | Orthopedic | No | 2022-02-16 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-01-31 |
| Applier, Cerclage | HXN | Class 1 | Orthopedic | No | 2022-02-01 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2022-02-14 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2022-02-16 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2022-02-01 |
| Template | HWT | Class 1 | Orthopedic | No | 2022-02-10 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2022-02-10 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2022-02-10 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2022-01-31 |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2022-12-07 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2022-02-17 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2022-02-10 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2022-01-31 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2022-03-18 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2022-02-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-02-09 |
Proprietary Names
Streamline TL Spinal Fixation System
Streamline® MIS Spinal Fixation System
Streamline Occipito-Cervico-Thoracic (OCT) System
Zimmer®* Cannulated Screw System
Streamline OCT Occipito-Cervico-Thoracic System
CODA Anterior Cervical Plate System
CervAlign Anterior Cervical Plate System
Songer® Spinal Cable System
EVOS Cabling 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
Fortilink-C
Fortilink-TS IBF System
Orthopaedic Cable System
SternaLock® XP Rigid Fixation System
TriALTIS Spine System
Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
Sternal Cable System
Fortilink-A IBF System
Fortilink-C IBF System
OSSE-LIGN
Streamline Navigated Instruments
TiPlus
Fortilink-TC IBF System
Trochanteric Reattachment Device System (TRD)
CRIMP POSITIONING PINS
Tyber Medical Distal Radius Plating System
Cable-Ready®* Cable Grip System: Greater Trochanteric Reattachment Device (GTR)
Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
Fortilink Interbody Fusion (IBF) Device with TETRAfuse 3D Technology
Cerclage Button
Cable-Ready®* Cable Grip System: Hex Button
DVR® Crosslock Wrist Spanning Plate
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device