510(k) Report

Devices descending from K920392

2 later devices reach Isola Spine System: Plate-Rod Combination through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981113Pediatric PRCAcromed Corp.19981—
+2K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—