Identity
- Trade Name
- Patriot Spinal Fixation System FDA UDI
- Generic Name
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
- Device Name
- Pedicle Finder, Straight FDA UDI
- Model / Reference
- 10-99-0002 FDA UDI
- Description
- Pedicle Finder, Straight FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00811771032578 FDA UDI
- 510(k) Number
- K180324 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Abdominal/ENT/orthopaedic surgical probe, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Abdominal/ENT/orthopaedic surgical probe, reusable
Patriot Spinal Fixation System by Valorus Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Abdominal/ENT/orthopaedic surgical probe, reusable.
- DRM Thoracic Pedicle Feeler 1 — Captiva Spine · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- ISOLA — Depuy Spine, Inc. · Class I
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- Invictus — ALPHATEC SPINE, INC. · Class I
- Optima™ Spinal System — CG MedTech Co., Ltd. · Class I
- General Instruments — ALPHATEC SPINE, INC. · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Cleared under the same submission
K180324 also covers:
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
- Patriot Spinal Fixation System — VALORUS SPINE, LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Valorus Spine, Llc
Sources (1)
- FDA UDI ef583924-0709-49dc-bcfd-e2480e0a332c 35 fields · synced Jun 6, 2026