CoLink Mini Plating System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191535 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 CoLink Mini Plating System is a surgical orthopedic device classified as a metallic bone plate designed for internal fixation of long bone fractures. It provides stable fixation through interlocking screws and a modular plate system, enabling precise alignment and load distribution during bone healing.
This system is intended for use in orthopedic surgery settings and is supplied as a reusable surgical instrument set. The plates and screws are metallic, intended for single-use per patient procedure, and must be handled under sterile conditions. The device is authorised under FDA 510K clearance (K191535) and complies with the Medical Device Directive (MDD). Sizes and configurations are specified in the accompanying surgical instructions.
Frequently asked questions
What types of bone fractures is the CoLink® Mini Plating System designed to treat, and how does it achieve stability during healing?
The CoLink® Mini Plating System is designed for internal fixation of long bone fractures, providing stable fixation through interlocking screws and a modular plate system. This setup allows for precise alignment of the bone fragments and even load distribution, which supports proper healing by maintaining the fracture site in the correct position during recovery.
Is the CoLink® Mini Plating System reusable, and if so, what components are single-use?
The CoLink® Mini Plating System itself is supplied as a reusable surgical instrument set. However, the metallic plates and screws are intended for single-use per patient procedure and must be handled under sterile conditions to ensure patient safety and infection control.
How should the CoLink® Mini Plating System be stored, and what precautions should be taken?
Since the plates and screws are metallic and intended for single-use, they must be stored in a sterile environment to maintain integrity. The reusable surgical instrument set should follow standard surgical instrument storage protocols, including cleaning, disinfection, and packaging to prevent contamination. Always refer to the manufacturer’s instructions for specific storage guidelines.
What regulatory pathways does the CoLink® Mini Plating System follow, and how does this affect its use?
The CoLink® Mini Plating System is authorized under FDA 510K clearance (K191535) and complies with the Medical Device Directive (MDD). This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets EU safety and performance standards. Clinicians and buyers can rely on these clearances when selecting the device for orthopedic procedures.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191535 | Class II | Active |
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Manufacturer
- Manufacturer
- In2Bones USA, LLC
Sources (2)
- FDA 510(k) K191535 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026