510(k) Report

Devices descending from K060361

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K182470Plateau Spacer SystemLife Spine20180—
+8K182182YUKON OCT Spinal SystemK2m20185—
+8K180690Navigation InstrumentsGlobus Medical, Inc.20189—
+8K171444YUKON OCT Spinal SystemK2m, Inc.2017133
+8K162266The Cranial Fusion SystemLife Spine, Inc.20171—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+9K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+9K200896Solstice CCILife Spine, Inc.20200—
+9K193129Yukon OCT Spinal SystemK2m, Inc.202001
+9K183381Navigation Enabled InstrumentsStryker20191—
+10K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K232432E3D™-A Interbody SystemEvolution Spine20248—
+10K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+10K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+10K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+11K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+11K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+11K240368E3D™-A Interbody SystemEvolution Spine20247—
+11K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+11K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+11K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+11K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+11K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+12K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+12K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+12K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—