F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non Sterile
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072432 FDA 510(k)
- FDA Product Code
- JEC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The F3 Fractured Finger Fixator is an orthopedic device indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers. It provides external skeletal fixation sufficient to obtain and maintain concentric reduction of the fracture-dislocation.
The device is available in both sterile and non-sterile configurations. It is a Class II medical device with FDA 510(k) clearance (K072432) under product code JEC and regulation number 888.3040. The device is manufactured by Hand Biomechanics Lab, Inc. and is intended for use in orthopedic applications.
Frequently asked questions
What is the F3 Fractured Finger Fixator used for?
The F3 Fractured Finger Fixator is an orthopedic device indicated for the treatment of acute, unstable dorsal fracture-dislocations of the proximal interphalangeal (PIP) joint of the fingers. It provides external skeletal fixation to obtain and maintain concentric reduction of the fracture-dislocation.
Is the F3 Fractured Finger Fixator available in different configurations?
Yes, the device is available in both sterile and non-sterile configurations. This allows healthcare providers to choose the appropriate option based on their clinical needs and sterile field requirements.
What is the regulatory status of the F3 Fractured Finger Fixator?
The F3 Fractured Finger Fixator is a Class II medical device with FDA 510(k) clearance (K072432) under product code JEC and regulation number 888.3040. It is manufactured by Hand Biomechanics Lab, Inc. and is intended for use in orthopedic applications.
How is the F3 Fractured Finger Fixator supplied?
The device is supplied in both sterile and non-sterile configurations. The sterile version is ready for immediate surgical use, while the non-sterile version may require additional sterilization procedures before use in a clinical setting.
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: F3 Fractured Finger Fixator, Sterile (Model: Fcs 400) and Non Sterile, F3 Fractured Finger Fixator, Sterile (model: Fcs 400) And Non Sterile ..., F3 Fractured Finger Fixator, Sterile (Model: Fcs 400) and Non Sterile
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072432 | Class II | Active |
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Manufacturer
- Manufacturer
- Hand Biomechanics Lab, Inc.
Sources (1)
- FDA 510(k) K072432 24 fields · synced Oct 6, 2026