510(k) Report

Devices descending from K103287

348 later devices reach Synthes 6.0 Cocr and CPT TI-3 Rods through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+7K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+7K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K222789VADER® Pedicle System, G21 CementIcotec AG202352
+7K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+7K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+7K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+7K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+7K200896Solstice CCILife Spine, Inc.20200—
+7K193129Yukon OCT Spinal SystemK2m, Inc.202001
+7K183381Navigation Enabled InstrumentsStryker20191—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+8K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+8K240368E3D™-A Interbody SystemEvolution Spine20247—
+8K232628VADER® Pedicle SystemIcotec AG20241—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+8K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+8K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+8K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+8K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+8K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+9K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+9K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—