Neoview Plating System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by In2Bones SAS
Identifiers
- 510(k) Number
- K160995 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neoview Plating System is a surgical orthopedic device designed for internal fixation of long bone fractures. It consists of plates and screws used to stabilize and support bone fragments during the healing process, ensuring proper alignment and structural integrity.
This system is supplied sterile and intended for single-use in orthopedic surgical settings. It is classified under the product code HRS and has received FDA 510(k) clearance, MDD, and MDR authorizations. The system is engineered for use in procedures requiring precise fixation, with components tailored for compatibility with standard orthopedic instrumentation.
Frequently asked questions
What types of long bone fractures is the Neoview Plating System designed to stabilize, and how does it ensure proper alignment during healing?
The Neoview Plating System is specifically designed for internal fixation of long bone fractures, providing stabilization and support to bone fragments. Its plates and screws are engineered to maintain proper alignment and structural integrity during the healing process, ensuring the bone remains fixed in the correct position while it regenerates.
Is the Neoview Plating System intended for reuse in surgical settings, or is it meant to be used only once?
The Neoview Plating System is explicitly intended for single-use in orthopedic surgical settings. This design ensures patient safety by preventing cross-contamination and maintaining sterility, which is critical for effective fracture healing and infection control.
How is the Neoview Plating System supplied, and what does the sterile packaging ensure for the surgical procedure?
The Neoview Plating System is supplied sterile, meaning it is pre-packaged and prepared to meet surgical standards for cleanliness. This ensures that when used in the operating room, the components are free from contaminants, reducing the risk of infection and maintaining optimal conditions for precise fracture fixation.
What regulatory pathways has the Neoview Plating System undergone, and how does this affect its use in clinical settings?
The Neoview Plating System has undergone FDA 510(k) clearance, as well as MDD and MDR authorizations, confirming its compliance with stringent regulatory standards. This means it is approved for use in clinical settings where internal fixation of long bone fractures is required, ensuring both safety and efficacy for surgeons and patients.
Are the components of the Neoview Plating System compatible with standard orthopedic surgical tools, and how does this benefit the surgical workflow?
Yes, the Neoview Plating System is engineered to be compatible with standard orthopedic instrumentation. This compatibility streamlines the surgical workflow, allowing surgeons to use familiar tools and techniques while ensuring precise placement of plates and screws for optimal fracture stabilization.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K160995 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones SAS
Sources (2)
- FDA 510(k) K160995 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026