510(k) Report

Devices descending from K103072

233 later devices reach Revere Sacral Plates through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+10K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—