510(k) Report

Devices descending from K050461

742 later devices reach Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+10K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+10K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+10K182470Plateau Spacer SystemLife Spine20180—
+10K182182YUKON OCT Spinal SystemK2m20185—
+10K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+10K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+10K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+11K233366SYMPHONY OCT SystemMedos International SARL20230—
+11K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+11K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+11K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+11K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+11K200896Solstice CCILife Spine, Inc.20200—
+11K193129Yukon OCT Spinal SystemK2m, Inc.202001
+11K183381Navigation Enabled InstrumentsStryker20191—
+12K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+12K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+12K232432E3D™-A Interbody SystemEvolution Spine20248—
+12K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+12K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+12K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+13K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+13K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+13K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+13K240368E3D™-A Interbody SystemEvolution Spine20247—
+13K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+13K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+13K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+13K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+13K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+14K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+14K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+14K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—