510(k) Report

Devices descending from K041203

657 later devices reach Summit Oct Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+8K242042TriALTIS™ Spine SystemMedos International SARL20241—
+8K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2…Stryker Leibinger GmbH & Co KG20244—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+8K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+9K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update…Stryker Leibinger GmbH & Co KG20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+9K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleStryker Instruments20250—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K241517Q Guidance System; Mako Spine System;Stryker Leibinger GmbH & Co KG20242—
+9K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+9K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+9K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+9K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+9K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+10K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+10K240368E3D™-A Interbody SystemEvolution Spine20247—
+10K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+10K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+10K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+10K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+10K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+10K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+11K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+11K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+11K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+11K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+11K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+11K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—