510(k) Report

Devices descending from K030682

15 later devices reach Calcium Hydroxylapatite Implant, Icc and 0.5CC, Models 8038-3, 8037-3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101426Ceros TCP GranulesMathys, Ltd.20100—
+1K081784Mastergraft PuttyMedtronic Sofamor Danek20081—
+1K042707Grafton Plus DBM PasteOsteotech, Inc.2005013
+1K033398Laryngeal Augmentation ImplantBioform, Inc.200310—
+2K140374Mastergraft PuttyMedtronic Sofamor Danek USA, Inc.20140—
+2K071663VF Gel PlusCoapt Systems, Inc.20084—
+2K060815Juliesse Injectable Laryngeal Augmentation ImplantBioform Medical, Inc.200661
+3K081816Vocalis and Vocalis SMCytophil, Inc.20090—
+3K081815Vocalis GelCytophil, Inc.20090—
+3K080956Modification to VF Gel PlusCoapt Systems, Inc.20083—
+3K070090Radiesse Laryngeal ImplantBioform Medical, Inc.20075—
+4K180631Silk VoiceSofregen Medical, Inc.20181—
+4K121795Calcium Hydroxylapatite Vocal Fold ImplantCytophil, Inc.20130—
+4K083783VF LiquigelCoapt Systems, Inc.20090—
+5K240919Silk Voice (SMI-04)Sofregen Medical20240—