Interphalangeal Joint Fusion Device Range
FDA 510(k)Class II (US FDA 510(k))
by Neosteo
Identifiers
- 510(k) Number
- K191424 FDA 510(k)
- FDA Product Code
- HWC 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 Interphalangeal Joint Fusion Device Range consists of metallic implants designed to stabilize two bone fragments to facilitate bone fusion. Implants are available in various lengths and angulations.
Used by surgeons in clinical settings for lesser toe reconstruction procedures such as hammertoe, claw toe, and mallet toe. The device received FDA 510(k) clearance on 2019-08-28 under K-number K191424 and is manufactured by Neosteo in Nantes, France.
Frequently asked questions
What is the Interphalangeal Joint Fusion Device Range used for?
The device is used by surgeons in clinical settings to stabilize bone fragments during lesser toe reconstruction procedures, including hammertoe, claw toe, and mallet toe, to facilitate bone fusion.
How is the Interphalangeal Joint Fusion Device Range supplied?
The device consists of metallic implants available in various lengths and angulations, designed for surgical implantation to stabilize bone fragments in lesser toe procedures.
What regulatory pathway was used for the Interphalangeal Joint Fusion Device Range?
The device received FDA 510(k) clearance via the traditional pathway, as indicated by the clearance_type field and the K-number K191424.
Who manufactures the Interphalangeal Joint Fusion Device Range and where is it made?
The device is manufactured by Neosteo in Nantes, France, as stated in the manufacturer and address fields.
Is the Interphalangeal Joint Fusion Device Range intended for reuse?
The device data does not specify whether the implant is single-use or reusable; therefore, reuse status cannot be determined from the provided information.
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: Interphalangeal Joint Fusion Device Range (K191424) — FDA 510 (k ..., Neosteo Interphalangeal Joint Fusion Range - allmed.wiki, Interphalangeal Joint Fusion Device Range — FDA K191424, Interphalangeal Joint Fusion Device Range (K191424) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191424 | Class II | Active |
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Manufacturer
- Manufacturer
- Neosteo
Sources (1)
- FDA 510(k) K191424 24 fields · synced Sep 19, 2026