510(k) Report

Devices descending from K131820

8 later devices reach Avamax Vertebral Balloon System, 8G, Avamax Vertebral Balloon System, 10G… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+1K150523AVAmax Vertebral BalloonCare Fusion20151—
+1K141419ZvplastyZavation, LLC2014036
+2K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+2K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+2K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation20160—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—