510(k) Report

Devices descending from K133698

6 later devices reach Synapse System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+1K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+2K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+3K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+4K223852VySpan™ PCT SystemVy Spine, LLC20231—
+5K232167VySpan™ PCT SystemVy Spine, LLC20230—