Graftgun Universal Graft Delivery System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180937 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Graftgun Universal Graft Delivery System is a device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. It is designed for use via direct visualization or minimally invasive techniques.
The system is supplied as a reusable device and is authorized under FDA 510(k) clearance (K180937). It is manufactured by SurGenTec, LLC and is intended for use is restricted to orthopedic surgical settings as specified in the device authorization.
Frequently asked questions
What is the Graftgun Universal Graft Delivery System used for?
The Graftgun Universal Graft Delivery System is intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. It supports both direct visualization and minimally invasive techniques, making it suitable for various bone grafting procedures in orthopedic settings as specified in its authorization.
Is the Graftgun Universal Graft Delivery System reusable or single-use?
The Graftgun Universal Graft Delivery System is supplied as a reusable device, meaning it is designed to be cleaned, sterilized, and used multiple times in accordance with the manufacturer’s instructions. This distinguishes it from single-use graft delivery systems and supports cost-effective use in orthopedic surgical environments.
How is the Graftgun Universal Graft Delivery System supplied and what is its regulatory authorization?
The system is supplied as a reusable device and is authorized under FDA 510(k) clearance with the K-number K180937. It was determined to be substantially equivalent to a predicate device, and its clearance is classified as special. The device is manufactured by SurGenTec, LLC and is intended for use in orthopedic surgical settings only.
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: Bone Graft Delivery | SurGenTec Graftgun®, Bone Graft Delivery Devices | Graftgun® | SurGenTec, PDF SurGenTec brings a new advancement to bone graft delivery with our ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180937 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgentec, Llc
Sources (1)
- FDA 510(k) K180937 24 fields · synced Sep 22, 2026