Identifiers
- 510(k) Number
- K142030 FDA 510(k)
- FDA Product Code
- MQP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The STGC-Lordotic is an orthopedic device indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, such as fracture. It is designed to be used with autograft and supplemental fixation.
The device is supplied as a single-use item and is cleared through the FDA 510(k) pathway under product code MQP. It is manufactured by Cardinal Spine, LLC and is intended for use in surgical procedures.
Frequently asked questions
What is the STGC-Lordotic device used for?
The STGC-Lordotic is an orthopedic device designed to replace a collapsed, damaged, or unstable vertebral body in the thoracolumbar spine (T1-L5). It is commonly used to address conditions caused by tumor or trauma, such as fracture.
How is the STGC-Lordotic device supplied?
The device is supplied as a single-use item. It is intended for use in surgical procedures and is designed to be used with autograft and supplemental fixation.
What is the regulatory status of the STGC-Lordotic?
The STGC-Lordotic is cleared through the FDA 510(k) pathway under product code MQP. It was reviewed by the Orthopedic advisory committee and determined to be substantially equivalent to predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: STGC-LORDOTIC by CARDINAL SPINE, LLC | FDA 510 (k) Summary, K142030 FDA 510 (k) - STGC-LORDOTIC | Cardinal Spine, LLC, STGC-LORDOTIC (K142030) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142030 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Spine Llc
- FDA Applicant
- Cardinal Spine, LLC
Sources (1)
- FDA 510(k) K142030 24 fields · synced Sep 26, 2026