510(k) Report

Devices descending from K972317

14 later devices reach Montgomery Thyroplasty Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K991324Titanium Vocal Fold Medializing Implant, Models 5001 001 (Female), and 5001 003 (Male)Heinz Kurz19990—
+1K982294Xomed Silicone Pre-Form BlocksXomed, Inc.199812—
+2K013243Coaptite Laryngeal Augmentation System 1CC & O.5CC, Models 0008021-1, 0008022-1Bioform, Inc.2002111
+3K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+3K081815Vocalis GelCytophil, Inc.20090—
+3K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+3K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+4K180631Silk VoiceSofregen Medical, Inc.20181—
+4K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+4K071663VF Gel PlusCoapt Systems, Inc.20084—
+4K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+5K240919Silk Voice (SMI-04)Sofregen Medical20240—
+5K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+6K083783VF LiquigelCoapt Systems, Inc.20090—