510(k) Report

Devices descending from K093419

13 later devices reach Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM (10 Gauge)0705-115-500… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152557Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L.20162—
+1K141419ZvplastyZavation, LLC2014036
+1K130430Ivas 10MM and 15MM Balloon CatheterStryker Corporation201351
+1K123942Stryker Ivas Balloon CatheterStryker Corporation201351
+1K113154Ivas Balloon CatheterStryker Corporation20123—
+1K113477Ivas 20MM (10 Gauge) Balloon CatheterStryker Instruments, Instruments Div.20127—
+1K110604VBB SystemSynthes201111
+1K103807Ivas 2-10MM (10 Guage) Ballon CatheterStryker Corporation20119—
+2K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20180—
+2K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon…Stryker Corporation20181—
+2K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L.20171—
+2K130146Synthes Synflate Vertevral Balloon SystemSynthes (Usa), LLC20130—
+3K200763Osteo-site Vertebral BalloonIzi Medical20200—