510(k) Report

Devices descending from K002858

749 later devices reach Xia Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+11K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+11K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+11K243693NEO Pedicle Screw System™Neo Medical SA20240—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+11K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+11K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K211957QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.20213—
+11K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+11K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+11K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+11K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+11K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+11K182470Plateau Spacer SystemLife Spine20180—
+11K182182YUKON OCT Spinal SystemK2m20185—
+11K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+11K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+11K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+12K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K233366SYMPHONY OCT SystemMedos International SARL20230—
+12K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+12K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+12K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+12K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+12K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+12K200896Solstice CCILife Spine, Inc.20200—
+12K193129Yukon OCT Spinal SystemK2m, Inc.202001
+12K183381Navigation Enabled InstrumentsStryker20191—
+13K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+13K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+13K232432E3D™-A Interbody SystemEvolution Spine20248—
+13K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+13K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+13K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+14K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+14K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+14K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+14K240368E3D™-A Interbody SystemEvolution Spine20247—
+14K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+14K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+14K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+14K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+14K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+15K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+15K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+15K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—