System, Vocal Cord Medialization

FDA product code MIX · Class II (moderate risk) · 21 CFR 874.3620 · Ear, Nose, Throat

17510(k) clearances
0PMA approvals
1recalls
Implantimplanted device

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K240919Silk Voice (SMI-04)MIX · Special Sofregen Medical05/03/2024SE
K180631Silk VoiceMIX · Traditional Sofregen Medical, Inc.11/08/2018SE
K150400Renu GelMIX · Special Cytophil, Inc.04/06/2015SE
K121795Calcium Hydroxylapatite Vocal Fold ImplantMIX · Traditional Cytophil, Inc.02/22/2013SE
K083783VF LiquigelMIX · Traditional Coapt Systems, Inc.09/11/2009SE
K081816Vocalis and Vocalis SMMIX · Traditional Cytophil, Inc.01/05/2009SE
K081815Vocalis GelMIX · Traditional Cytophil, Inc.01/05/2009SE
K080956Modification to VF Gel PlusMIX · Special Coapt Systems, Inc.04/25/2008SE
K071663VF Gel PlusMIX · Traditional Coapt Systems, Inc.02/15/2008SE
K070090Radiesse Laryngeal ImplantMIX · Special Bioform Medical, Inc.03/01/2007SE
K060815Juliesse Injectable Laryngeal Augmentation ImplantMIX · Special Bioform Medical, Inc.04/18/2006SE
K033398Laryngeal Augmentation ImplantMIX · Traditional Bioform, Inc.12/12/2003SE
K011554Lorenz Lactosorb Vocal Medialization ImplantMIX · Traditional Biomet, Inc.06/26/2001SE
K001466Vocom Silicone SystemMIX · Traditional Smith & Nephew, Inc.07/26/2000SE
K000533Vocom Implant- 8MMMIX · Traditional Smith & Nephew, Inc.03/01/2000SE
K983525Gore Revox Thyroplasty ImplantMIX · Traditional W. L. Gore & Associates, Inc.12/10/1998SE
K972317Montgomery Thyroplasty Implant SystemMIX · Traditional Boston Medical Products, Inc.09/18/1997SE

Recalls

RecallProductFirmInitiated
Z-0367-2016 Class IIPROLARYN Injectable Implant 1.0 cc Gel, Model No. 8602M0K5. A restorable implant…The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient… Merz North America, Inc.10/26/2015Terminated