510(k) Report

Devices descending from K974749

311 later devices reach Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+8K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+8K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+8K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+8K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+9K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—