510(k) Report

Devices descending from K080526

9 later devices reach Sierra System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231654NorthStar OCT SystemSeaspine, Inc.20230—
+1K193615NorthStar™ OCT Spinal SystemSeaSpine Orthopedics Corporation20201—
+1K133698Synapse SystemSynthes USA Products, LLC20146—
+2K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180—
+2K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC20145—
+3K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC20153—
+4K213394Vy Spine™ VySpan™ PCT SystemVy Spine, LLC20212—
+5K223852VySpan™ PCT SystemVy Spine, LLC20231—
+6K232167VySpan™ PCT SystemVy Spine, LLC20230—