MIX · System, Vocal Cord Medialization
Ear, Nose, Throat · 21 CFR 874.3620 · Class 2
Overview
| Product Code | MIX |
|---|---|
| Device Name | System, Vocal Cord Medialization |
| Regulation | 21 CFR 874.3620 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| Implant | Yes |
Identification
Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240919 | Silk Voice (SMI-04) | Sofregen Medical | May 3, 2024 | SESE |
| K180631 | Silk Voice | Sofregen Medical, Inc. | Nov 8, 2018 | SESE |
| K150400 | Renu Gel | Cytophil, Inc. | Apr 6, 2015 | SESE |
| K121795 | CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANT | Cytophil, Inc. | Feb 22, 2013 | SESE |
| K083783 | VF LIQUIGEL | Coapt Systems, Inc. | Sep 11, 2009 | SESE |
| K081816 | VOCALIS AND VOCALIS SM | Cytophil, Inc. | Jan 5, 2009 | SESE |
| K081815 | VOCALIS GEL | Cytophil, Inc. | Jan 5, 2009 | SESE |
| K080956 | MODIFICATION TO VF GEL PLUS | Coapt Systems, Inc. | Apr 25, 2008 | SESE |
| K071663 | VF GEL PLUS | Coapt Systems, Inc. | Feb 15, 2008 | SESE |
| K070090 | RADIESSE LARYNGEAL IMPLANT | Bioform Medical, Inc. | Mar 1, 2007 | SESE |
| K060815 | JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT | Bioform Medical, Inc. | Apr 18, 2006 | SESE |
| K033398 | LARYNGEAL AUGMENTATION IMPLANT | Bioform, Inc. | Dec 12, 2003 | SESE |
| K011554 | LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT | Biomet, Inc. | Jun 26, 2001 | SESE |
| K001466 | VOCOM SILICONE SYSTEM | Smith & Nephew, Inc. | Jul 26, 2000 | SESE |
| K000533 | VOCOM IMPLANT- 8MM | Smith & Nephew, Inc. | Mar 1, 2000 | SESE |
| K983525 | GORE REVOX THYROPLASTY IMPLANT | W. L. Gore & Associates, Inc. | Dec 10, 1998 | SESE |
| K972317 | MONTGOMERY THYROPLASTY IMPLANT SYSTEM | Boston Medical Products, Inc. | Sep 18, 1997 | SESE |
Top Applicants
- Cytophil, Inc. — 4 clearances
- Coapt Systems, Inc. — 3 clearances
- Bioform Medical, Inc. — 2 clearances
- Smith & Nephew, Inc. — 2 clearances
- Bioform, Inc. — 1 clearance
