Pioneer Surgical Technology, Inc.
Registration 1833824FEI 1000115331Marquette, MI
Owner/operator: Pioneer Surgical Technology, Inc.
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 85
- Added, last 12 months
- 14
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 85
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KTT | Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage CablesAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | 21 CFR 888.3030 | K151907 |
| KTT | Cable-Ready® Cable Grip SystemAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentAdded Aug 10, 2026 | Class 2 | 21 CFR 888.3030 | K261271 |
| KTT | Cable-Ready®* Cable Grip System: Greater Trochanteric Reattachment Device (GTR)Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Class 2 | 21 CFR 888.3030 | K000734 |
| KWP | Streamline TL Spinal Fixation SystemAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | Streamline Occipito-Cervico-Thoracic (OCT) SystemAppliance, Fixation, Spinal Interlaminal | Class 2 | 21 CFR 888.3050 | — |
| KWP | TriALTIS Spine SystemAppliance, Fixation, Spinal InterlaminalAdded Dec 3, 2025 | Class 2 | 21 CFR 888.3050 | — |
| KWQ | CODA Anterior Cervical Plate SystemAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | K230993 |
| KWQ | CervAlign Anterior Cervical Plate SystemAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | — |
| KWQ | CODA Anterior Cervical Plate SystemAppliance, Fixation, Spinal Intervertebral Body | Class 2 | 21 CFR 888.3060 | K222493 |
| JDQ | Cable-Ready® Cable Grip SystemCerclage, FixationAdded Aug 10, 2026 | Class 2 | 21 CFR 888.3010 | K261271 |
| JDQ | Orthopaedic Cable SystemCerclage, Fixation | Class 2 | 21 CFR 888.3010 | K992616 |
| JDQ | OSSE-LIGNCerclage, Fixation | Class 2 | 21 CFR 888.3010 | — |
and 73 more on your full dossier
What changed
- Aug 10, 2026Listing added: KTT — Cable-Ready® Cable Grip System (K261271)
- Dec 3, 2025Listing added: KWP — TriALTIS Spine System
- Aug 10, 2026Listing added: JDQ — Cable-Ready® Cable Grip System (K261271)
- Jun 29, 2026Listing added: OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Jul 8, 2026Listing added: HRS — VOLT Ankle Trauma 2.7/3.5 Plating System; VOLT Calcaneus 2.7 Plating System
- Aug 10, 2026Listing added: HRS — Cable-Ready® Cable Grip System (K261271)
- Dec 11, 2025Listing added: HRS — Geminus Volar Distal Radius Plating System
- Aug 5, 2026Listing added: HRS — VOLT Medial Distal Femur Plate 3.5
- Jun 19, 2026Listing added: HRS — Plate, Fixation, Bone
- Aug 10, 2026Listing added: HWC — Cable-Ready® Cable Grip System (K261271)
- Dec 11, 2025Listing added: HWC — Geminus Volar Distal Radius Plating System
- Mar 31, 2026Listing added: HWC — Tyber Medical Anatomical Plating System
- Dec 3, 2025Listing added: NKB — TriALTIS Spine System
- Aug 10, 2026Listing added: HTN — Cable-Ready® Cable Grip System (K261271)