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MIX — System, Vocal Cord Medialization Class II

FDA Device Classification

Classification Details

Product Code
MIX
Device Class
Class II
Regulation Number
874.3620
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240919sofregen medicalSilk Voice (SMI-04)May 3, 2024
K180631sofregen medicalSilk VoiceNovember 8, 2018
K150400cytophilRenu GelApril 6, 2015
K121795cytophilCALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTFebruary 22, 2013
K083783coapt systemsVF LIQUIGELSeptember 11, 2009
K081816cytophilVOCALIS AND VOCALIS SMJanuary 5, 2009
K081815cytophilVOCALIS GELJanuary 5, 2009
K080956coapt systemsMODIFICATION TO VF GEL PLUSApril 25, 2008
K071663coapt systemsVF GEL PLUSFebruary 15, 2008
K070090bioform medicalRADIESSE LARYNGEAL IMPLANTMarch 1, 2007
K060815bioform medicalJULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANTApril 18, 2006
K033398bioformLARYNGEAL AUGMENTATION IMPLANTDecember 12, 2003
K011554biometLORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANTJune 26, 2001
K001466smith and nephewVOCOM SILICONE SYSTEMJuly 26, 2000
K000533smith and nephewVOCOM IMPLANT- 8MMMarch 1, 2000
K983525w.l. gore and associatesGORE REVOX THYROPLASTY IMPLANTDecember 10, 1998
K972317boston medical productsMONTGOMERY THYROPLASTY IMPLANT SYSTEMSeptember 18, 1997