510(k) Report

Devices descending from K110694

227 later devices reach Concorde Bullet Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K260038E3D™-C Interbody SystemEvolution Spine20261—
+7K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+7K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+7K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+7K253335CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20250—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+7K251431FIX-C PEEK ACIF SA SystemJeil Medical Corporation20250—
+7K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+7K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+7K242734ZSFab Cervical Interbody System; ZSFab Lumbar Interbody SystemZsfab20243—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K232877FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous…K&J Consulting Corporation20231—
+7K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+7K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230329F3D Interbody SystemCorelink, LLC20230—
+7K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+7K221578Hexanium ACIFSpinevision, S.A.S.20224—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K211258Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA…Medtronic Sofamor Danek USA, Inc.202175—
+7K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+8K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+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—
+8K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+8K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232432E3D™-A Interbody SystemEvolution Spine20248—
+9K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K223326Axiom PSR SystemRestor3D202301
+9K230026SqualeImplanet, S.A.20230—
+9K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—