Ogmend Implant Enhancement System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K223075 FDA 510(k)
- FDA Product Code
- QVI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3043 FDA 510(k)
- Regulation Number
- 888.3043 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ogmend Implant Enhancement System is a Screw Sleeve Bone Fixation Device for Spine (OpenFDA classification), designed to improve screw-bone interface stability in orthopedic applications. It functions as an implantable sleeve that enhances fixation between screws and bone, particularly in compromised or high-risk scenarios where traditional methods may fail to achieve secure attachment.
This device is intended for single-use in spine surgery and is classified as a Class II medical device under FDA regulations. It is supplied sterile and requires surgical implantation, with available sizes corresponding to specific screw diameters. The system carries an FDA 510(k) clearance (K223075) for spine applications and is regulated under the Spinal Fixation Devices category (regulation number 888.3043).
Frequently asked questions
What is the Ogmend® Implant Enhancement System specifically designed to improve in spine surgeries?
The Ogmend® Implant Enhancement System is designed to improve screw-bone interface stability in spine surgeries. It acts as an implantable sleeve that strengthens the connection between screws and bone, particularly in cases where traditional fixation methods may not provide sufficient attachment, such as in compromised or high-risk scenarios.
Is the Ogmend® Implant Enhancement System intended for reuse or is it meant to be used only once?
The Ogmend® Implant Enhancement System is explicitly intended for single-use in spine surgery. This design ensures patient safety and sterility, as it is supplied sterile and meant to be implanted during a single surgical procedure.
How is the Ogmend® Implant Enhancement System supplied, and what does that mean for surgical preparation?
The Ogmend® Implant Enhancement System is supplied sterile, meaning it is pre-packaged and ready for immediate use in the operating room without additional sterilization. This ensures that the device is clean and safe for implantation right out of the packaging, simplifying surgical preparation.
What sizes are available for the Ogmend® Implant Enhancement System, and how do they relate to screw diameters?
The Ogmend® Implant Enhancement System comes in sizes that correspond to specific screw diameters. While the exact sizes are not detailed in the provided data, the system is designed to fit standard screw sizes used in spine surgeries, ensuring compatibility with existing surgical hardware for enhanced fixation.
How is the Ogmend® Implant Enhancement System regulated, and what does that mean for its use in clinical settings?
The Ogmend® Implant Enhancement System is regulated under the FDA’s 510(k) clearance process, specifically under the Spinal Fixation Devices category (regulation number 888.3043). It carries an FDA 510(k) clearance (K223075) for spine applications, meaning it has been deemed substantially equivalent to a legally marketed predicate device. This clearance ensures that the device meets FDA standards for safety and effectiveness, allowing clinicians to use it with confidence in spine surgeries.
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: Technology — Woven Orthopedics, Woven Orthopedics, PDF Woven Orthopedics Secures Second Fda Spine Clearance Ogmend Now ..., PDF February 27, 2023 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K223075 | Class II | Active |
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Manufacturer
- Manufacturer
- Woven Orthopedic Technologies
Sources (1)
- FDA 510(k) K223075 24 fields · synced Sep 19, 2026