510(k) Report

Devices descending from P980048

1,422 later devices reach Bak/Cervical (Bak/C) Interbody Fusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K101301Stalif MidlineCentinel Spine2010474—
+3K100802Aesculap Implant Systems Sibd Spinal SystemAesculap Implant Systems, Inc.2010461—
+3K100043Coroent XLR Standalone SystemNuvasive, Inc.2010744—
+3K092211Chesapeake Spinal SystemK2m, Inc.2010450—
+3K091301Life Spine Stand-Alone Spacer SystemLife Spine2009473—
+3K083475Lucent MagnumSpinal Elements, Inc.2009834—
+3K081711Lucent Magnum+Spinal Elements, Inc.20080—
+3K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc.20087531
+4K262726NeckTune™ SA Cervical CageMedyssey Co., Ltd.20260—
+4K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+4K261049Scala® TLSpineart SA20260—
+4K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+4K261408SABER-XA SystemElevation Spine20260—
+4K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+4K2530413d Cage CervicalFims Co., Ltd.20260—
+4K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+4K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K260837VersaLift Expandable SystemLife Spine, Inc.20260—
+4K254202MectaLIF 3D Metal AnteriorMedacta International S.A.20260—
+4K261067BEE PLIF CageNGMedical GmbH20260—
+4K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+4K260660SABER-C SystemElevation Spine20261—
+4K252774Uni-C Cervical Cage SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+4K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+4K254017SWINGO-3D Lumbar Cage SystemImplanet20260—
+4K253583LUX Expandable Lumbar Interbody SystemXenix Medical20260—
+4K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+4K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+4K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+4K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)20250—
+4K252610ZSFab Lumbar Interbody SystemZsfab, Inc.20251—
+4K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+4K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+4K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+4K250540SABER-C SystemElevation Spine20252—
+4K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+4K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+4K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+4K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+4K242771Tesera-k PL System and Tesera-k XL SystemKyocera Medical Technologies, Inc.20251—
+4K250605EVOL® ha – Hyper C Cervical Interbody Fusion SystemCutting Edge Spine, LLC20250—
+4K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+4K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+4K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+4K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+4K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+4K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+4K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+4K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+4K241992Catalyft™ LS Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.20240—
+4K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemCtl Medical Corporation20240—
+4K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+4K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+4K240889ARTFX Lumbar PEEK CagesArtfx Medical20244—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+4K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+4K241438Signus Tetris™ St; Signus Tetris™ R StSignus Medizintechnik GmbH20240—
+4K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+4K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+4K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+4K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+4K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+4K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+4K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+4K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+4K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+4K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+4K234150Lucent® XPSpinal Elements20240—
+4K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+4K233075“BioGend” Interbody Fusion System 001 CageBiogend Therapeutics Co., Ltd.20240—
+4K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+4K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc.20240—
+4K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+4K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemCuriteva, Inc.20242—
+4K230872Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction…Shanghai Sanyou Medical Co, Ltd.20231—
+4K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+4K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+4K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+4K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC20230—
+4K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+4K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+4K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+4K231147Hammerdesis™ Interphalangeal Fusion SystemIntelivation20230—
+4K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+4K232150ZSFab Cervical Interbody SystemZsfab, Inc.20234—
+4K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231808QUASAR Standalone ACIF SystemGS Medical Co., Ltd.20230—
+4K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+4K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—