510(k) Report

Devices descending from K041282

633 later devices reach Modification to TSRH Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+11K200896Solstice CCILife Spine, Inc.20200—
+11K190751Connector SystemOrthofix, Inc.20193—
+11K190376PASS LP Spinal SystemMedicrea International SA201915
+11K182470Plateau Spacer SystemLife Spine20180—
+12K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+12K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+12K262094E3D™-C Interbody SystemEvolution Spine20260—
+12K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+12K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+12K260038E3D™-C Interbody SystemEvolution Spine20261—
+12K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+12K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+12K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+12K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+12K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+12K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+12K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+12K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+12K240368E3D™-A Interbody SystemEvolution Spine20247—
+12K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+12K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+12K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+12K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+12K230989Rod Registration FrameNu Vasive, Incorporated20230—
+12K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+13K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+13K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+13K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+13K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+13K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—