510(k) Report

Devices descending from K972023

23 later devices reach Sleep-in Bone Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101060Siesta Medical, Inc., Prelude Tongue Suspension SystemSiesta Medical, Inc.201015—
+1K040417Pillar Palatal Implant SystemRestore Medical, Inc.20040—
+1K981677Repose Bone Screw SystemInfluence, Inc.1999162
+2K122391Medtronic Xomed, Inc.Medtronic Xomed, Inc.20134—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K103179Prelude II Tounge Suspension SystemSiesta Medical, Inc.201014—
+2K011723Anti-Snoring Device or AsdPi Medical20024—
+3K183310Encore SystemSiesta Medical, Inc.20192—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K133680Encore SystemSiesta Medical, Inc.20143—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+3K110623Pillar Palatal Implant SystemMedtronic Xomed, Inc.20122—
+3K110127Prelude Iii Tongue Suspension SystemSiesta Medical, Inc.201113—
+4K201238Encore SystemSiesta Medical, Inc.20201—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+4K181107Elevo® Kit Snoring Intervention DeviceZelegent, Inc.20181—
+4K111179Encore Tongue Suspension System (Monofilament #1 Suspension Suture), Encore Tongue…Siesta Medical, Inc.20116—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—
+5K213475Elevo Snoring Intervention SetZelegent, Inc.20220—
+5K213159Encore SystemSiesta Medical, Inc.20210—
+5K121440Encore Tongue Suspension System Encore Removal-Titration KitSiesta Medical, Inc.20124—
+5K121814Encore Tongue Suspension SystemSiesta Medical, Inc.20120—