510(k) Report

Devices descending from K922504

8 later devices reach Isola (R) Tandem Connector through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K141509Isola and Expedium Growing Spine SystemsMedos Sarl20146—
+2K161028K2M Growing Spine SystemK2m, Inc.20163—
+2K142587Vertical Expandable Prosthetic Titanium RibDepuy Synthes Spine, Inc.201411
+3K233105RESPONSE™ Rib and Pelvic SystemOrthoPediatrics Corp.20240—
+3K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—