Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)
FDA 510(k)Class II (US FDA 510(k))
by Heinz Kurz
Identifiers
- 510(k) Number
- K991324 FDA 510(k)
- FDA Product Code
- KHJ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3620 FDA 510(k)
- Regulation Number
- 874.3620 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Titanium Vocal Fold Medializing Implant is a medical device used to address unilateral vocal fold paralysis by providing structural support to the vocal fold. It is surgically implanted and available in two sizes for male and female patients. The titanium material allows for intra-operative adjustment by the surgeon to fit the patient's anatomy, retaining its bent shape due to its balance of elasticity and rigidity.
The device is supplied as a single-use implant and is classified as a Class II medical device under product code KHJ. It has received FDA 510(k) clearance with K number K991324 and is classified as Polymer, ENT Synthetic-polyamide (mesh or foil material). The device is manufactured by Heinz Kurz and is regulated under special controls.
Frequently asked questions
What is the Titanium Vocal Fold Medializing Implant used for?
The Titanium Vocal Fold Medializing Implant is a medical device used to address unilateral vocal fold paralysis by providing structural support to the vocal fold. It is surgically implanted to help restore proper vocal function.
How is the Titanium Vocal Fold Medializing Implant supplied?
The device is supplied as a single-use implant and is classified as a Class II medical device under product code KHJ. It is manufactured by Heinz Kurz and comes in two specific models: 5001 001 for female patients and 5001 003 for male patients.
Can the Titanium Vocal Fold Medializing Implant be adjusted during surgery?
Yes, the titanium material allows for intra-operative adjustment by the surgeon to fit the patient's anatomy. The implant retains its bent shape due to its balance of elasticity and rigidity, providing both flexibility and stability during and after the procedure.
What is the regulatory status of the Titanium Vocal Fold Medializing Implant?
The device has received FDA 510(k) clearance with K number K991324 and is classified as Polymer, ENT Synthetic-polyamide (mesh or foil material). It is regulated under special controls as a Class II medical device for the treatment of unilateral vocal fold paralysis.
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: Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and ..., Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and ..., K991324 FDA 510 (k) - TITANIUM VOCAL FOLD MEDIALIZING IMPLANT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991324 | Class II | Active |
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Manufacturer
- Manufacturer
- Heinz Kurz
Sources (1)
- FDA 510(k) K991324 24 fields · synced Sep 21, 2026